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Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

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ClinicalTrials.gov Identifier: NCT01213251
Recruitment Status : Completed
First Posted : October 1, 2010
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Acute Myocardial Infarction
Pacing Therapy
Cardiac Remodeling
Heart Failure
Interventions Device: Single Site Pacing
Device: Dual Site Pacing
Enrollment 129
Recruitment Details 3 patients exited study prior to randomization.
Pre-assignment Details  
Arm/Group Title Single Site Pacing Dual Site Pacing Control
Hide Arm/Group Description Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
Period Title: Overall Study
Started 40 41 45
Completed 34 [1] 37 [1] 34 [1]
Not Completed 6 4 11
Reason Not Completed
Death             2             1             2
Exit             3             2             8
Protocol Violation             1             1             0
Missed 18-Month Follow-up             0             0             1
[1]
Patients that had the 18-Month follow-up visit
Arm/Group Title Single Site Pacing Dual Site Pacing Control Total
Hide Arm/Group Description Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management. Total of all reporting groups
Overall Number of Baseline Participants 40 41 45 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 45 participants 126 participants
59  (10) 60  (12) 54  (11) 58  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 45 participants 126 participants
Female
12
  30.0%
9
  22.0%
12
  26.7%
33
  26.2%
Male
28
  70.0%
32
  78.0%
33
  73.3%
93
  73.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 45 participants 126 participants
Asian 0 1 0 1
Black or African American 3 3 5 11
Hispanic or Latino 0 1 3 4
White or Caucasian 19 16 18 53
Not reportable per local laws or regulations 18 20 19 57
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 41 participants 45 participants 126 participants
28  (6) 30  (5) 29  (4) 29  (5)
Systolic Blood Pressure (mmHg)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 40 participants 41 participants 45 participants 126 participants
114  (16) 118  (21) 119  (17) 117  (18)
Diastolic Blood Pressure (mmHg)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 40 participants 41 participants 45 participants 126 participants
73  (11) 71  (12) 74  (11) 73  (11)
Heart Rate from Physical Exam (BPM)  
Mean (Standard Deviation)
Unit of measure:  BPM
Number Analyzed 40 participants 41 participants 45 participants 126 participants
80  (15) 80  (13) 79  (14) 79  (14)
Left Ventricular Ejection Fraction (LVEF)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 40 participants 41 participants 45 participants 126 participants
43  (9) 43  (10) 45  (9) 44  (9)
Left Ventricular End Diastolic Volume (LVEDV)  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 40 participants 41 participants 45 participants 126 participants
107  (25) 107  (31) 116  (29) 111  (29)
Left Ventricular End Systolic Volume (LVESV)  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 40 participants 41 participants 45 participants 126 participants
62  (23) 62  (22) 65  (24) 63  (23)
QRS Width (msec)  
Mean (Standard Deviation)
Unit of measure:  Msec
Number Analyzed 40 participants 41 participants 45 participants 126 participants
94  (17) 97  (17) 88  (13) 93  (16)
NYHA   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 45 participants 126 participants
I 9 12 11 32
II 10 10 16 36
III 15 12 9 36
IV 0 0 0 0
Subject does not have heart failure 6 7 8 21
Missing 0 0 1 1
[1]
Measure Description: The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.
Minnesota Living with Heart Failure Questionnaire (MLWHF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 41 participants 45 participants 126 participants
21  (25) 29  (26) 32  (29) 28  (27)
[1]
Measure Description: Minnesota Living with Heart Failure Questionnaire (MLWHF) is a health-related quality of life questionnaire. The scale ranges from 0 to 105. In particular, the lower the score the better is the patient’s quality of life.
1.Primary Outcome
Title Change in Left Ventricular End Diastolic Volume (LVEDV)
Hide Description

Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.

Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.

Time Frame Baseline - 18 Month Follow Up Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.
Arm/Group Title Pooled Pacing Control
Hide Arm/Group Description:
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
Overall Number of Participants Analyzed 64 34
Mean (95% Confidence Interval)
Unit of Measure: mL
16.4
(8.9 to 23.9)
15.8
(5.5 to 26.2)
2.Secondary Outcome
Title Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
Hide Description Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.
Time Frame 18 months post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.
Arm/Group Title Single Site Pacing Dual Site Pacing
Hide Arm/Group Description:
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Overall Number of Participants Analyzed 38 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
System-Related Adverse Event
0.59
(0.41 to 0.73)
0.68
(0.50 to 0.80)
System Related Complication
0.86
(0.70 to 0.94)
0.87
(0.71 to 0.94)
Procedure Related Adverse Event
0.57
(0.40 to 0.71)
0.66
(0.48 to 0.78)
Procedure Related Complication
0.84
(0.68 to 0.92)
0.84
(0.68 to 0.93)
System Related or Procedure Related Complication
0.79
(0.62 to 0.89)
0.82
(0.65 to 0.91)
3.Secondary Outcome
Title Frequency of Hospitalization for Cardiovascular Events
Hide Description Number of hospitalizations related to cardiovascular events.
Time Frame Baseline - 18 Month Follow Up Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.
Arm/Group Title Single Site Pacing Dual Site Pacing Control
Hide Arm/Group Description:
Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
Overall Number of Participants Analyzed 38 37 45
Measure Type: Number
Unit of Measure: participants
0 27 22 30
1 6 9 11
2 3 3 0
3 1 1 3
4 0 0 0
5 1 1 0
6 0 0 0
7 0 0 0
8 0 1 0
9 0 0 1
4.Secondary Outcome
Title Change in New York Heart Association (NYHA) Functional Class
Hide Description

The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.

NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as “Improved”. Similarly for “Worsened” (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects’ NYHA Class is not different than baseline, then the subject was classified as "No Change".

Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.

Time Frame Baseline - 18 Month Follow Up Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.
Arm/Group Title Pooled Pacing Control
Hide Arm/Group Description:
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
Overall Number of Participants Analyzed 68 33
Measure Type: Number
Unit of Measure: participants
Improved 26 13
No Change 25 10
Worsened 17 10
5.Secondary Outcome
Title Change in 6-minute Walk Test Distance
Hide Description

Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.

Change is defined as month 18 minus baseline.

Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.

Time Frame 1 Month - 18 Month Follow Up Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.
Arm/Group Title Pooled Pacing Control
Hide Arm/Group Description:
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
Overall Number of Participants Analyzed 63 28
Mean (95% Confidence Interval)
Unit of Measure: meters
37.6
(5.8 to 69.3)
15.6
(-32.1 to 63.2)
6.Secondary Outcome
Title Change in Quality of Life
Hide Description

Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.

Change is defined as month 18 minus baseline.

Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.

Time Frame Baseline - 18 Month Follow Up Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.
Arm/Group Title Pooled Pacing Control
Hide Arm/Group Description:
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
Overall Number of Participants Analyzed 69 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.4
(-5.3 to 6.1)
-0.1
(-8.5 to 8.3)
7.Secondary Outcome
Title Incidence of Sudden Cardiac Death and Total Mortality
Hide Description

Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.

Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.

Time Frame 18 Months post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.
Arm/Group Title Pooled Pacing Control
Hide Arm/Group Description:
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
Overall Number of Participants Analyzed 75 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects at risk
All-cause Death
4.0
(1.3 to 12.0)
4.7
(1.2 to 17.5)
Sudden-cardiac Death
1.4
(0.2 to 9.2)
2.4
(0.3 to 16.1)
8.Secondary Outcome
Title Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
Hide Description

Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.

Variables resulting in statistical significant (p<0.05) are reported.

Time Frame Baseline - 18 Month Follow Up Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.
Arm/Group Title All Subjects
Hide Arm/Group Description:
All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.
Overall Number of Participants Analyzed 98
Mean (Standard Error)
Unit of Measure: regression coefficient
Age -0.75  (0.26)
Days from MI to Implant* -3.78  (1.64)
Baseline LVEF -0.87  (0.35)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Site Pacing Dual Site Pacing Control
Hide Arm/Group Description Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
All-Cause Mortality
Single Site Pacing Dual Site Pacing Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Site Pacing Dual Site Pacing Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/40 (55.00%)      24/41 (58.54%)      20/45 (44.44%)    
Blood and lymphatic system disorders       
Anaemia  1/40 (2.50%)  2 0/41 (0.00%)  0 0/45 (0.00%)  0
Cardiac disorders       
Acute coronary syndrome  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Acute myocardial infarction  0/40 (0.00%)  0 0/41 (0.00%)  0 3/45 (6.67%)  5
Angina pectoris  2/40 (5.00%)  2 1/41 (2.44%)  2 3/45 (6.67%)  5
Angina unstable  1/40 (2.50%)  1 1/41 (2.44%)  1 1/45 (2.22%)  1
Atrial fibrillation  0/40 (0.00%)  0 3/41 (7.32%)  7 1/45 (2.22%)  1
Atrial flutter  1/40 (2.50%)  1 1/41 (2.44%)  2 0/45 (0.00%)  0
Atrioventricular block complete  2/40 (5.00%)  2 0/41 (0.00%)  0 0/45 (0.00%)  0
Atrioventricular block second degree  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Cardiac aneurysm  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Cardiac arrest  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Cardiac failure congestive  1/40 (2.50%)  1 1/41 (2.44%)  1 4/45 (8.89%)  6
Cardiac perforation  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Cardiorenal syndrome  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Coronary artery disease  2/40 (5.00%)  2 1/41 (2.44%)  1 1/45 (2.22%)  1
Decompensated Heart Failure  2/40 (5.00%)  4 5/41 (12.20%)  13 6/45 (13.33%)  6
Dresslers syndrome  1/40 (2.50%)  1 0/41 (0.00%)  0 1/45 (2.22%)  1
Ischaemic cardiomyopathy  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Myocardial infarction  1/40 (2.50%)  1 1/41 (2.44%)  1 1/45 (2.22%)  1
Supraventricular tachycardia  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Ventricular extrasystoles  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Ventricular fibrillation  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Ventricular tachycardia  1/40 (2.50%)  1 0/41 (0.00%)  0 1/45 (2.22%)  1
Congenital, familial and genetic disorders       
Gastrointestinal arteriovenous malformation  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Gastrointestinal disorders       
Colitis ulcerative  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  2
Duodenal ulcer haemorrhage  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Inguinal hernia  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Rectal haemorrhage  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
General disorders       
Chest pain  2/40 (5.00%)  2 1/41 (2.44%)  1 2/45 (4.44%)  2
Device infusion issue  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Device stimulation issue  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Implant site haemorrhage  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Lead dislodgement  2/40 (5.00%)  3 4/41 (9.76%)  4 0/45 (0.00%)  0
Multi-organ failure  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Non-cardiac chest pain  0/40 (0.00%)  0 1/41 (2.44%)  1 4/45 (8.89%)  4
Undersensing  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations       
Appendicitis  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Diverticulitis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Erysipelas  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Implant site infection  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Incision site infection  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Pneumonia  1/40 (2.50%)  1 1/41 (2.44%)  1 3/45 (6.67%)  6
Urinary tract infection  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Viral myocarditis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Coronary artery restenosis  0/40 (0.00%)  0 0/41 (0.00%)  0 2/45 (4.44%)  2
Lumbar vertebral fracture  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Investigations       
International normalised ratio increased  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Metabolism and nutrition disorders       
Fluid overload  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Hyponatraemia  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Malnutrition  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Joint effusion  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Vertebral foraminal stenosis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder transitional cell carcinoma  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Lung adenocarcinoma  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Rectal adenoma  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Nervous system disorders       
Dizziness  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Hypoxic-ischaemic encephalopathy  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Ischaemic stroke  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Lumbar radiculopathy  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Syncope  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Psychiatric disorders       
Depression suicidal  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  2/40 (5.00%)  2 0/41 (0.00%)  0 0/45 (0.00%)  0
Acute prerenal failure  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Nephrolithiasis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Renal failure  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Renal impairment  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Dyspnoea  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Epistaxis  2/40 (5.00%)  3 0/41 (0.00%)  0 0/45 (0.00%)  0
Haemoptysis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Pleural effusion  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Pneumothorax  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Pulmonary oedema  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Respiratory failure  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis contact  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Vascular disorders       
Aortic aneurysm  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Arterial stenosis  1/40 (2.50%)  1 2/41 (4.88%)  2 1/45 (2.22%)  1
Arterial thrombosis  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Hypotension  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Orthostatic hypotension  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Subclavian steal syndrome  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Thrombosis  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Site Pacing Dual Site Pacing Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/40 (50.00%)      25/41 (60.98%)      27/45 (60.00%)    
Blood and lymphatic system disorders       
Increased tendency to bruise  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Thrombocytopenia  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Cardiac disorders       
Angina pectoris  2/40 (5.00%)  2 1/41 (2.44%)  1 2/45 (4.44%)  2
Angina unstable  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Atrial fibrillation  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Atrioventricular block complete  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Bradycardia  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Cardiac failure congestive  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Cardiomegaly  0/40 (0.00%)  0 1/41 (2.44%)  1 1/45 (2.22%)  1
Coronary artery disease  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Decompensated Heart Failure  1/40 (2.50%)  1 3/41 (7.32%)  3 4/45 (8.89%)  5
Intracardiac thrombus  1/40 (2.50%)  1 3/41 (7.32%)  3 1/45 (2.22%)  1
Palpitations  2/40 (5.00%)  2 1/41 (2.44%)  1 1/45 (2.22%)  1
Sinus bradycardia  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Ventricular fibrillation  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Ventricular tachycardia  2/40 (5.00%)  2 1/41 (2.44%)  1 0/45 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Endocrine disorders       
Hypogonadism  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Eye disorders       
Keratitis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain upper  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Constipation  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Dental discomfort  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Dyspepsia  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Dysphagia  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Large intestine polyp  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Nausea  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
General disorders       
Adverse drug reaction  1/40 (2.50%)  1 3/41 (7.32%)  3 0/45 (0.00%)  0
Chest pain  2/40 (5.00%)  2 3/41 (7.32%)  3 2/45 (4.44%)  2
Device alarm issue  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Device capturing issue  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Device electrical impedance issue  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Device infusion issue  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Device malfunction  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Device occlusion  0/40 (0.00%)  0 1/41 (2.44%)  3 0/45 (0.00%)  0
Device pacing issue  4/40 (10.00%)  4 1/41 (2.44%)  1 0/45 (0.00%)  0
Device stimulation issue  8/40 (20.00%)  13 4/41 (9.76%)  4 0/45 (0.00%)  0
Fatigue  0/40 (0.00%)  0 1/41 (2.44%)  1 1/45 (2.22%)  1
Implant site bruising  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Implant site oedema  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Implant site pain  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Implant site scar  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Implant site swelling  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Lead dislodgement  2/40 (5.00%)  2 0/41 (0.00%)  0 0/45 (0.00%)  0
Medical device pain  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Non-cardiac chest pain  0/40 (0.00%)  0 1/41 (2.44%)  1 2/45 (4.44%)  2
Oedema peripheral  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Oversensing  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Peripheral swelling  2/40 (5.00%)  2 0/41 (0.00%)  0 0/45 (0.00%)  0
Phantom shocks  0/40 (0.00%)  0 2/41 (4.88%)  2 0/45 (0.00%)  0
Undersensing  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Vessel puncture site haematoma  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Hepatobiliary disorders       
Cholelithiasis  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Immune system disorders       
Drug hypersensitivity  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Infections and infestations       
Acarodermatitis  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Bronchitis  2/40 (5.00%)  2 1/41 (2.44%)  1 0/45 (0.00%)  0
Diverticulitis  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Echinococciasis  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Gastroenteritis norovirus  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Impetigo  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Implant site infection  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Influenza  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Upper respiratory tract infection  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Injury, poisoning and procedural complications       
Accidental overdose  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Cardiac vein dissection  0/40 (0.00%)  0 2/41 (4.88%)  2 0/45 (0.00%)  0
Cardiac vein perforation  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Contusion  2/40 (5.00%)  2 0/41 (0.00%)  0 2/45 (4.44%)  2
Foreign body  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Incision site pain  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Laceration  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Ligament sprain  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Procedural pain  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Traumatic haematoma  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Wound dehiscence  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Investigations       
Biopsy skin  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Blood pressure increased  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Blood urine present  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Body temperature increased  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
C-reactive protein increased  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Echocardiogram abnormal  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Hepatic enzyme increased  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
International normalised ratio increased  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  2
Liver function test abnormal  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Metabolism and nutrition disorders       
Gout  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Hypocalcaemia  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Hypokalaemia  1/40 (2.50%)  1 0/41 (0.00%)  0 1/45 (2.22%)  1
Hyponatraemia  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1/40 (2.50%)  1 3/41 (7.32%)  3 0/45 (0.00%)  0
Musculoskeletal pain  0/40 (0.00%)  0 0/41 (0.00%)  0 2/45 (4.44%)  2
Myalgia  0/40 (0.00%)  0 1/41 (2.44%)  1 2/45 (4.44%)  2
Pain in extremity  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Renal adenoma  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Nervous system disorders       
Cervicobrachial syndrome  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Dizziness  2/40 (5.00%)  2 0/41 (0.00%)  0 1/45 (2.22%)  1
Headache  1/40 (2.50%)  1 0/41 (0.00%)  0 1/45 (2.22%)  1
Paraesthesia  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Sciatica  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Syncope  3/40 (7.50%)  3 0/41 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders       
Acute stress disorder  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Stress  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Renal and urinary disorders       
Haematuria  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Renal failure  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Menopausal symptoms  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1/40 (2.50%)  1 1/41 (2.44%)  1 0/45 (0.00%)  0
Dyspnoea  0/40 (0.00%)  0 4/41 (9.76%)  4 3/45 (6.67%)  3
Dyspnoea exertional  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Epistaxis  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Pulmonary hypertension  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Respiratory failure  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Sinus congestion  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Sleep apnoea syndrome  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis allergic  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Ingrowing nail  1/40 (2.50%)  2 0/41 (0.00%)  0 0/45 (0.00%)  0
Photodermatosis  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Vascular disorders       
Hypertension  0/40 (0.00%)  0 1/41 (2.44%)  1 0/45 (0.00%)  0
Hypotension  1/40 (2.50%)  1 1/41 (2.44%)  1 3/45 (6.67%)  3
Orthostatic hypotension  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Peripheral arterial occlusive disease  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
Peripheral artery thrombosis  0/40 (0.00%)  0 0/41 (0.00%)  0 1/45 (2.22%)  1
Venous stenosis  1/40 (2.50%)  1 0/41 (0.00%)  0 0/45 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: PRomPT Clinical Team
Organization: Medtronic plc
Phone: +1 800-328-2518
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01213251     History of Changes
Other Study ID Numbers: PRomPT
First Submitted: September 28, 2010
First Posted: October 1, 2010
Results First Submitted: August 8, 2016
Results First Posted: December 15, 2016
Last Update Posted: December 15, 2016