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Trial record 13 of 13 for:    digitalis

PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00293241
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : June 30, 2015
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cardiovascular Diseases
Intervention Device: Managed Ventricular Pacing programmed ON/OFF
Enrollment 630
Recruitment Details Study start February 2006; last patient enrolled in August 2009.
Pre-assignment Details Patients were electronically randomized. 25 patients were excluded from analysis due to double entry (7) or no evidence of Patient Informed Consent Form (PIC) signed (18).
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description Managed Ventricular Pacing programmed on Managed Ventricular Pacing programmed off: conventional pacing
Period Title: Overall Study
Started 299 306
Completed 263 265
Not Completed 36 41
Reason Not Completed
Lost to Follow-up             9             16
Physician Decision             23             17
Withdrawal by Subject             4             8
Arm/Group Title MVP ON MVP OFF Total
Hide Arm/Group Description Managed Ventricular Pacing programmed on Managed Ventricular Pacing programmed off: conventional pacing Total of all reporting groups
Overall Number of Baseline Participants 299 306 605
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants 306 participants 605 participants
75.1  (10.9) 74.3  (10.8) 74.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 306 participants 605 participants
Female
125
  41.8%
115
  37.6%
240
  39.7%
Male
174
  58.2%
191
  62.4%
365
  60.3%
1.Primary Outcome
Title Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant
Hide Description

Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.

Hospitalization is defined as:

  • admission to hospital involving one overnight stay or
  • emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition

Cardiovascular is defined as new or worsening:

  • heart failure (HF),
  • angina,
  • myocardial infarction (MI),
  • any arrhythmia,
  • stroke,
  • transient ischemic attack (TIA),
  • acute peripheral vascular emergencies,
  • pulmonary embolism.
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing > 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: number of participants
43 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments

Analysis:Time to first cardiovascular hospitalization (CV hosp)

H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)

Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD

Power calculation:

The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.

Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.927
Confidence Interval (2-Sided) 95%
0.612 to 1.405
Estimation Comments

Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition

CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism

2.Secondary Outcome
Title Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.
Hide Description Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
Death or CV hospitalization at 1 year 33 30
Death or CV hospitalization at 2 years 66 57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments

Analysis:Time to first all cause death or cardiovascular hospitalization

H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization

Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.127
Confidence Interval (2-Sided) 95%
0.808 to 1.570
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant
Hide Description

Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:

  • 7 days in a row with device diagnostic showing 20 or more hours in AT/AF or
  • a cardioversion was done to terminate AT/AF or
  • the patient is during 2 consecutive follow-up (FU) visits in AT/AF
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
Persistent AT/AF at 1 year 27 17
Persistent AT/AF at 2 years 41 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.521
Confidence Interval (2-Sided) 95%
0.954 to 2.424
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant
Hide Description

Time to development of permanent AF fulfilling one of the following criteria:

  • 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or
  • 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
Permanent AF at 1 year 8 3
Permanent AF at 2 years 11 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.425
Confidence Interval (2-Sided) 95%
0.573 to 3.543
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Ventricular Pacing Percentage
Hide Description Endpoint: Cumulative percentage ventricular pacing documented in the device memory
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Median (Inter-Quartile Range)
Unit of Measure: Percentage Ventricular Pacing
5
(1 to 41)
86
(40 to 98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments

Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm

H0:distribution %VP MVP=distribution %VP DDD

Ha:distribution %VP MVP≠distribution %VP DDD

Ha:

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time
Hide Description Endpoint: LVEF (%) difference between 2 year post implant and baseline
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Mean (Standard Deviation)
Unit of Measure: LVEF (%) difference
-1.2  (10.5) 1.4  (9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
7.Secondary Outcome
Title Change in New York Heart Association (NYHA) Functional Class
Hide Description

Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.

II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.

III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.

IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.

Time Frame Baseline, one year and 2 year post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: Participants
No Heart Failure (Baseline) 64 92
Class I (Baseline) 99 87
Class II (Baseline) 108 108
Class III (Baseline) 19 9
Class IV (Baseline) 1 3
No Heart Failure (12-months) 67 71
Class I (12-months) 69 72
Class II (12-months) 97 86
Class III (12-months) 5 10
Class IV (12-months) 0 2
No Heart Failure (24-months) 53 73
Class I (24-months) 68 69
Class II (24-months) 83 69
Class III (24-months) 11 9
Class IV (24-months) 0 1
8.Secondary Outcome
Title Change in Use of Anticoagulation
Hide Description Endpoint: Use of Anticoagulation at enrollment and every follow-up visit
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
Patients with Medication Records (Baseline) 298 304
Patients Using Anticoagulants (Baseline) 75 72
Patients with Medication Records (1-month) 271 285
Patients Changing Anticoagulants Use (1-month) 24 21
Patients with Medication Records (12-months) 246 257
Patients Changing Anticoagulants Use (12-months) 28 31
Patients with Medication Records (24-months) 226 231
Patients Changing Anticoagulants Use (24-months) 27 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Repeated measures logistic regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Repeated measures logistic regression
Comments [Not Specified]
9.Secondary Outcome
Title Change in the Use of Cardiovascular Medication Over Time
Hide Description Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 298 304
Measure Type: Number
Unit of Measure: participants
Beta-blockers (Baseline), n=298, 304 129 116
Digitalis/digoxin (Baseline), n=298, 304 26 30
Calcium antagonists (Baseline), n=298, 304 54 63
Antiarrhythmic drugs (Baseline), n=298, 304 81 103
Beta-blockers (1-month), n=271, 285 117 111
Digitalis/digoxin (1-month), n=271, 285 24 28
Calcium antagonists (1-month), n=271, 285 49 60
Antiarrhythmic drugs (1-month), n=271, 285 75 98
Beta-blockers (12-months), n=246, 257 108 105
Digitalis/digoxin (12-months), n=246, 257 22 26
Calcium antagonists (12-months), n=246, 257 46 52
Antiarrhythmic drugs (12-months), n=246, 257 67 88
Beta-blockers (24-months), n=226, 231 104 93
Digitalis/digoxin (24-months), n=226, 231 20 22
Calcium antagonists (24-months), n=226, 231 36 47
Antiarrhythmic drugs (24-month), n=226, 231 58 76
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
10.Secondary Outcome
Title Incidence of High Voltage Therapies
Hide Description Endpoint: A high voltage therapy delivered
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
1 3
11.Secondary Outcome
Title Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant
Hide Description Time to patient death from any cause
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP Off
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
All-Cause Death at 1 year 17 7
All-Cause Death at 2 years 31 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP Off
Comments

Analysis:Time to all-cause death

H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.243
Confidence Interval (2-Sided) 95%
0.803 to 1.923
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Stroke
Hide Description Endpoint: Stroke
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
Stroke at 1 year 3 4
Stroke at 2 years 4 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.492
Confidence Interval (2-Sided) 95%
0.148 to 1.637
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Cardiovascular Related Hospitalizations
Hide Description Endpoint: Number of Cardiovascular hospitalizations per subject
Time Frame Implant to 4 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 53 46
Median (Inter-Quartile Range)
Unit of Measure: Number of CV Hospitalizations
1.0
(1 to 2)
1.0
(1 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments Statistical test for Number of subjects with CV hospitalization
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Duration of Cardiovascular Related Hospitalizations
Hide Description Endpoint: Duration of Cardiovascular Hospitalizations per subject
Time Frame Implant to 4 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:

Managed Ventricular Pacing programmed on

Managed Ventricular Pacing programmed ON/OFF: Device programming

Managed Ventricular Pacing programmed off: conventional pacing

Managed Ventricular Pacing programmed ON/OFF: Device programming

Overall Number of Participants Analyzed 53 46
Median (Inter-Quartile Range)
Unit of Measure: Days of CV hospitalizations
7.0
(4 to 12)
7.5
(3 to 14)
15.Secondary Outcome
Title Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients
Hide Description Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 28 21
Measure Type: Number
Unit of Measure: participants
0 0
16.Secondary Outcome
Title Change in PR Interval, Change in QRS Duration and Change in P-wave Duration
Hide Description Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Mean (Standard Deviation)
Unit of Measure: milliseconds
PR interval (ms) difference 24 month-baseline 11.6  (60.9) 10.8  (63.6)
QRS duration (ms) difference: 24 month-baseline 2.6  (32.4) 10.8  (41.8)
P-wave duration (ms) difference: 24 month-baseline 5.2  (41.2) 1.1  (38.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Patient Symptoms
Hide Description Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup
Time Frame Implant to 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 299 306
Measure Type: Number
Unit of Measure: participants
No symptoms (baseline) 175 193
Chest pain (baseline) 24 15
Dyspnea (baseline) 65 59
Dizziness/presyncope (baseline) 32 27
No Symptoms (12 months) 175 184
Chest pain (12 months) 11 12
Dyspnea (12 months) 36 38
Dizziness/presyncope (12 months) 9 17
No Symptoms (24 months) 158 160
Chest pain (24 months 15 10
Dyspnea (24 months) 39 40
Dizziness/presyncope (24 months) 8 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments No Symptoms (Baseline)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments No Symptoms (12 months)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments No Symptoms (24 Months)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Secondary Outcome
Title Atrial Pacing Percentage
Hide Description Endpoint: Cumulative percentage atrial pacing documented in the device memory
Time Frame 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 279 283
Median (Inter-Quartile Range)
Unit of Measure: percentage atrial pacing
68
(36 to 94)
78
(47 to 95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVP ON, MVP OFF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
19.Secondary Outcome
Title Health State
Hide Description Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.
Time Frame 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with health evaluation completed at 24 months follow-up
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description:
Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed off: conventional pacing
Overall Number of Participants Analyzed 219 224
Mean (Standard Deviation)
Unit of Measure: units on a Health State scale
70.6  (17.2) 70.3  (16.6)
Time Frame Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint.
Adverse Event Reporting Description

The following adverse events had to be reported:

  • SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition
  • Deaths
  • (S)ADE

The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.

 
Arm/Group Title MVP ON MVP OFF
Hide Arm/Group Description Managed Ventricular Pacing programmed on Managed Ventricular Pacing programmed off: conventional pacing
All-Cause Mortality
MVP ON MVP OFF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MVP ON MVP OFF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/299 (28.43%)      72/306 (23.53%)    
Cardiac disorders     
First cardiovascular hospitalization within 2 years after implant * [1]  43/299 (14.38%)  43 40/306 (13.07%)  40
Cardioversion within 2 years after implant * [2]  11/299 (3.68%)  15 9/306 (2.94%)  13
General disorders     
Death from any cause within 2 years after implant * [3]  31/299 (10.37%)  31 22/306 (7.19%)  22
Nervous system disorders     
Stroke within 2 years after implant * [4]  4/299 (1.34%)  4 6/306 (1.96%)  6
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalization (including emergency room) for cardiovascular causes: new or worsening heart failure, angina, myocardial infarction, any arrhythmia, stroke, transient ischemic attack, acute peripheral vascular emergencies, pulmonary embolism.
[2]
Cardioversion medically or electrically
[3]
All cause death
[4]
Stroke
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MVP ON MVP OFF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/299 (10.70%)      31/306 (10.13%)    
General disorders     
Non serious adverse events up to 2 years follow-up * [1]  32/299 (10.70%)  47 31/306 (10.13%)  39
*
Indicates events were collected by non-systematic assessment
[1]
All reported adverse events which were not serious
Atrial pacing % was not collected at implant, device programming in the MVP off arm was more often non-compliant than in MVP on arm, and 25% of the case report forms were sent without device data, possibly influencing device data related objectives
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: Lidwien Vainer
Organization: Medtronic Bakken
Phone: +31 433566752
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00293241     History of Changes
Other Study ID Numbers: Version 2-Aug 21, 2007
First Submitted: February 16, 2006
First Posted: February 17, 2006
Results First Submitted: October 9, 2014
Results First Posted: June 30, 2015
Last Update Posted: June 24, 2016