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Trial record 2 of 3 for:    Accent MRI™ Pacemaker

Accent Cardiac MRI Study (Accent Cardiac)

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: NCT02041702
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Bradycardia
Intervention Diagnostic Test: Non-Diagnostic Cardiac MRI scan
Enrollment 283
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cardiac MRI Scan Group Control Group
Hide Arm/Group Description Non-diagnostic cardiac MRI scan No non-diagnostic cardiac MRI scan
Period Title: Overall Study
Started [1] 140 143
Pre MRI Scan/ Pre Waitng [2] 129 140
Post MRI Scan/ Post Waiting [2] 129 140
Completed [3] 129 134
Not Completed 11 9
Reason Not Completed
Lost to Follow-up             1             6
Death             4             0
Withdrawal by Subject             4             3
Patient not confirmed as MRI compatible             1             0
Cardiac Resynchronization Therapy             1             0
[1]
Enrollment & Baseline
[2]
Control Group: No non diagnostic cardiac MRI scan, subjects waited for 45 minutes +/- 15 minutes
[3]
One month post MRI Scan
Arm/Group Title Cardiac MRI Scan Group Control Group Total
Hide Arm/Group Description Non-diagnostic cardiac MRI scan No non-diagnostic cardiac MRI scan Total of all reporting groups
Overall Number of Baseline Participants 140 143 283
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 143 participants 283 participants
71.4  (11.2) 67.4  (11.7) 69.4  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 143 participants 283 participants
Female
58
  41.4%
61
  42.7%
119
  42.0%
Male
82
  58.6%
82
  57.3%
164
  58.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 143 participants 283 participants
Hong Kong
15
  10.7%
15
  10.5%
30
  10.6%
China
3
   2.1%
4
   2.8%
7
   2.5%
Malaysia
2
   1.4%
3
   2.1%
5
   1.8%
Thailand
46
  32.9%
46
  32.2%
92
  32.5%
India
54
  38.6%
55
  38.5%
109
  38.5%
Singapore
20
  14.3%
20
  14.0%
40
  14.1%
Cardiomyopathy History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 143 participants 283 participants
Ischemic Cardiomyopathy
2
   1.4%
3
   2.1%
5
   1.8%
Non-ischemic Cardiomyopathy
1
   0.7%
0
   0.0%
1
   0.4%
Arrhythmia History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 143 participants 283 participants
Atrial Fibrillation
29
  20.7%
26
  18.2%
55
  19.4%
Atrial Flutter
7
   5.0%
6
   4.2%
13
   4.6%
Premature Ventricular
1
   0.7%
2
   1.4%
3
   1.1%
Monomorphic Ventricular Tachycardia
1
   0.7%
0
   0.0%
1
   0.4%
Supraventricular Tachycardia
1
   0.7%
0
   0.0%
1
   0.4%
Cardiovascular Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 143 participants 283 participants
Angiotensin Converting Enzyme Inhibitor
18
  12.9%
17
  11.9%
35
  12.4%
Angiotensin II Receptor Blockers
31
  22.1%
31
  21.7%
62
  21.9%
Beta-Blockers
31
  22.1%
19
  13.3%
50
  17.7%
Aldosterone Inhibitors
0
   0.0%
2
   1.4%
2
   0.7%
Antiarrhythmics (Class I)
3
   2.1%
1
   0.7%
4
   1.4%
Antiarrhythmics (Class II)
2
   1.4%
7
   4.9%
9
   3.2%
Anticoagulants
15
  10.7%
13
   9.1%
28
   9.9%
Antiplatelets
47
  33.6%
48
  33.6%
95
  33.6%
Calcium Channel Blockers
54
  38.6%
40
  28.0%
94
  33.2%
Cardiac Glycosides (Digitalis)
2
   1.4%
1
   0.7%
3
   1.1%
Diuretics
16
  11.4%
16
  11.2%
32
  11.3%
Nitrates
16
  11.4%
9
   6.3%
25
   8.8%
Other Medication
38
  27.1%
29
  20.3%
67
  23.7%
1.Primary Outcome
Title Freedom From MRI Scan-related Complications
Hide Description Number of subjects who were free from MRI scan-related complications
Time Frame MRI Visit ,1 Month Post MRI Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in Cardiac MRI Scan group who underwent an elective non-diagnostic cardiac MRI scan and completed all protocol specific visits were included in the analysis. Subjects who withdrew from the study before 1 month post MRI visit and had no MRI scan related complications were excluded.
Arm/Group Title Cardiac MRI Scan Group
Hide Arm/Group Description:
Non-diagnostic cardiac MRI scan
Overall Number of Participants Analyzed 123
Measure Type: Count of Participants
Unit of Measure: Participants
123
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac MRI Scan Group
Comments The hypothesis was: H0: P≤ 90% vs H1: P>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group
Type of Statistical Test Superiority
Comments The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Clopper-Pearson
Comments Clopper-Pearson CI for the binomial proportion
Method of Estimation Estimation Parameter Ratio
Estimated Value 100
Confidence Interval (2-Sided) 90%
97.6 to 100
Estimation Comments The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.
2.Primary Outcome
Title Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
Hide Description Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit
Time Frame MRI Visit ,1 Month Post MRI Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
Arm/Group Title Cardiac MRI Scan Group Control Group
Hide Arm/Group Description:
Non-diagnostic cardiac MRI scan
No non-diagnostic cardiac MRI scan
Overall Number of Participants Analyzed 111 117
Measure Type: Count of Participants
Unit of Measure: Participants
110
  99.1%
117
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac MRI Scan Group, Control Group
Comments

The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL>-10%

  • PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit
  • PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit
Type of Statistical Test Non-Inferiority
Comments The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Farrington-Manning Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 90%
-5.6 to 3.8
Estimation Comments The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.
3.Primary Outcome
Title Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
Hide Description Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit
Time Frame MRI Visit, 1 Month Post MRI Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
Arm/Group Title Cardiac MRI Scan Group Control Group
Hide Arm/Group Description:
Non-diagnostic cardiac MRI scan
No non-diagnostic cardiac MRI scan
Overall Number of Participants Analyzed 120 124
Measure Type: Count of Participants
Unit of Measure: Participants
118
  98.3%
124
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac MRI Scan Group, Control Group
Comments

The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL >-10%

  • PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
  • PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Type of Statistical Test Non-Inferiority
Comments The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Farrington-Manning test
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 90%
-6.2 to 2.8
Estimation Comments The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.
4.Primary Outcome
Title Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Hide Description Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Time Frame MRI Visit, 1 Month Post MRI Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
Arm/Group Title Cardiac MRI Scan Group Control Group
Hide Arm/Group Description:
Non-diagnostic cardiac MRI scan
No non-diagnostic cardiac MRI scan
Overall Number of Participants Analyzed 121 124
Measure Type: Count of Participants
Unit of Measure: Participants
105
  86.8%
111
  89.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac MRI Scan Group, Control Group
Comments

The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL >-10%

  • PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
  • PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Type of Statistical Test Non-Inferiority
Comments The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.
Statistical Test of Hypothesis P-Value 0.0446
Comments [Not Specified]
Method Farrington-Manning test
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 90%
-9.8 to 4.3
Estimation Comments The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.
5.Primary Outcome
Title Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Hide Description Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Time Frame MRI Visit, 1 Month Post MRI Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
Arm/Group Title Cardiac MRI Scan Group Control Group
Hide Arm/Group Description:
Non-diagnostic cardiac MRI scan
No non-diagnostic cardiac MRI scan
Overall Number of Participants Analyzed 104 111
Measure Type: Count of Participants
Unit of Measure: Participants
102
  98.1%
106
  95.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac MRI Scan Group, Control Group
Comments

The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL >-10%

  • PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
  • PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Type of Statistical Test Non-Inferiority
Comments The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Farrington-Manning test
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio Difference
Estimated Value 2.6
Confidence Interval (2-Sided) 90%
-3.2 to 8.4
Estimation Comments The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.
Time Frame Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected.
Adverse Event Reporting Description
  1. In the Serious Adverse Event Section, only SADE are reported.
  2. In the Other (Not Including Serious) Adverse Events Section, only ADE are reported.
  3. In the All-Cause Mortality Section, there are 4 deaths reported. All of them happened prior to cardiac MRI scan and were not related to study procedures.
 
Arm/Group Title Cardiac MRI Scan Group Control Group
Hide Arm/Group Description Non-diagnostic cardiac MRI scan No non-diagnostic cardiac MRI scan
All-Cause Mortality
Cardiac MRI Scan Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/140 (2.86%)      0/143 (0.00%)    
Hide Serious Adverse Events
Cardiac MRI Scan Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/140 (4.29%)      6/143 (4.20%)    
Cardiac disorders     
Acute Non-St Elevation Myocardial Infarction   0/140 (0.00%)  0 1/143 (0.70%)  1
Dressler's Syndrome   0/140 (0.00%)  0 1/143 (0.70%)  1
Righ Atrial Lead Dislodgement   0/140 (0.00%)  0 2/143 (1.40%)  2
Right Ventricular Lead Dislodgement   1/140 (0.71%)  1 0/143 (0.00%)  0
Ventricular Tachycardia Requiring Emergent Direct Current Cardioversion   1/140 (0.71%)  1 0/143 (0.00%)  0
General disorders     
Anaphylaxis, Anaphylactoid   1/140 (0.71%)  1 0/143 (0.00%)  0
Drug Allergy   1/140 (0.71%)  1 0/143 (0.00%)  0
Infections and infestations     
System Infection   0/140 (0.00%)  0 1/143 (0.70%)  1
Injury, poisoning and procedural complications     
Cardiac Tamponade   0/140 (0.00%)  0 1/143 (0.70%)  1
Pericardial Effusion   1/140 (0.71%)  1 0/143 (0.00%)  0
Vascular disorders     
Intracranial Hemorrhage   1/140 (0.71%)  1 0/143 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiac MRI Scan Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/140 (0.71%)      1/143 (0.70%)    
Cardiac disorders     
New Onset Paroxysmal Atrial Fibrillation   0/140 (0.00%)  0 1/143 (0.70%)  1
General disorders     
Retracted Right Atrial Lead   1/140 (0.71%)  1 0/143 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Clinical Project Leader Asia
Organization: Abbott (formerly St. Jude Medical)
Phone: 0085229967605
EMail: lyim@sjm.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02041702    
Other Study ID Numbers: CR-13-031-AP-LV
First Submitted: December 20, 2013
First Posted: January 22, 2014
Results First Submitted: August 18, 2017
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019