Trial Outcomes & Findings for Accent Cardiac MRI Study (NCT NCT02041702)

NCT ID: NCT02041702

Last Updated: 2019-08-21

Results Overview

Number of subjects who were free from MRI scan-related complications

Recruitment status

COMPLETED

Study phase

Target enrollment

283 participants

Primary outcome timeframe

MRI Visit ,1 Month Post MRI Visit

Results posted on

2019-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiac MRI Scan Group Non-diagnostic cardiac MRI scan	Control Group No non-diagnostic cardiac MRI scan
Overall Study STARTED	140	143
Overall Study Pre MRI Scan/ Pre Waitng	129	140
Overall Study Post MRI Scan/ Post Waiting	129	140
Overall Study COMPLETED	129	134
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Cardiac MRI Scan Group Non-diagnostic cardiac MRI scan	Control Group No non-diagnostic cardiac MRI scan
Overall Study Lost to Follow-up	1	6
Overall Study Death	4	0
Overall Study Withdrawal by Subject	4	3
Overall Study Patient not confirmed as MRI compatible	1	0
Overall Study Cardiac Resynchronization Therapy	1	0

Baseline Characteristics

Accent Cardiac MRI Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac MRI Scan Group n=140 Participants Non-diagnostic cardiac MRI scan	Control Group n=143 Participants No non-diagnostic cardiac MRI scan	Total n=283 Participants Total of all reporting groups
Age, Continuous	71.4 years STANDARD_DEVIATION 11.2 • n=5 Participants	67.4 years STANDARD_DEVIATION 11.7 • n=7 Participants	69.4 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	82 Participants n=7 Participants	164 Participants n=5 Participants
Region of Enrollment Hong Kong	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment China	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Malaysia	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Thailand	46 Participants n=5 Participants	46 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment India	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Region of Enrollment Singapore	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Cardiomyopathy History Ischemic Cardiomyopathy	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Cardiomyopathy History Non-ischemic Cardiomyopathy	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Arrhythmia History Atrial Fibrillation	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Arrhythmia History Atrial Flutter	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Arrhythmia History Premature Ventricular	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Arrhythmia History Monomorphic Ventricular Tachycardia	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Arrhythmia History Supraventricular Tachycardia	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cardiovascular Medication Angiotensin Converting Enzyme Inhibitor	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Cardiovascular Medication Angiotensin II Receptor Blockers	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Cardiovascular Medication Beta-Blockers	31 Participants n=5 Participants	19 Participants n=7 Participants	50 Participants n=5 Participants
Cardiovascular Medication Aldosterone Inhibitors	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Cardiovascular Medication Antiarrhythmics (Class I)	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Cardiovascular Medication Antiarrhythmics (Class II)	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Cardiovascular Medication Anticoagulants	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Cardiovascular Medication Antiplatelets	47 Participants n=5 Participants	48 Participants n=7 Participants	95 Participants n=5 Participants
Cardiovascular Medication Calcium Channel Blockers	54 Participants n=5 Participants	40 Participants n=7 Participants	94 Participants n=5 Participants
Cardiovascular Medication Cardiac Glycosides (Digitalis)	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Cardiovascular Medication Diuretics	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Cardiovascular Medication Nitrates	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Cardiovascular Medication Other Medication	38 Participants n=5 Participants	29 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: MRI Visit ,1 Month Post MRI Visit

Population: 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.

Number of subjects who were free from MRI scan-related complications

Outcome measures

Outcome measures
Measure	Cardiac MRI Scan Group n=123 Participants Non-diagnostic cardiac MRI scan	Control Group No non-diagnostic cardiac MRI scan
Freedom From MRI Scan-related Complications	123 Participants	—

PRIMARY outcome

Timeframe: MRI Visit ,1 Month Post MRI Visit

Population: 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

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

Outcome measures

Outcome measures
Measure	Cardiac MRI Scan Group n=111 Participants Non-diagnostic cardiac MRI scan	Control Group n=117 Participants No non-diagnostic cardiac MRI scan
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan	110 Participants	117 Participants

PRIMARY outcome

Timeframe: MRI Visit, 1 Month Post MRI Visit

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

Outcome measures

Outcome measures
Measure	Cardiac MRI Scan Group n=120 Participants Non-diagnostic cardiac MRI scan	Control Group n=124 Participants No non-diagnostic cardiac MRI scan
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan	118 Participants	124 Participants

PRIMARY outcome

Timeframe: MRI Visit, 1 Month Post MRI Visit

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

Outcome measures

Outcome measures
Measure	Cardiac MRI Scan Group n=121 Participants Non-diagnostic cardiac MRI scan	Control Group n=124 Participants No non-diagnostic cardiac MRI scan
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan	105 Participants	111 Participants

PRIMARY outcome

Timeframe: MRI Visit, 1 Month Post MRI Visit

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

Outcome measures

Outcome measures
Measure	Cardiac MRI Scan Group n=104 Participants Non-diagnostic cardiac MRI scan	Control Group n=111 Participants No non-diagnostic cardiac MRI scan
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan	102 Participants	106 Participants

Adverse Events

Cardiac MRI Scan Group

Serious events: 6 serious events

Other events: 1 other events

Deaths: 4 deaths

Control Group

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cardiac MRI Scan Group n=140 participants at risk Non-diagnostic cardiac MRI scan	Control Group n=143 participants at risk No non-diagnostic cardiac MRI scan
Cardiac disorders Acute Non-St Elevation Myocardial Infarction	0.00% 0/140 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.70% 1/143 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
General disorders Anaphylaxis, Anaphylactoid	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Injury, poisoning and procedural complications Cardiac Tamponade	0.00% 0/140 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.70% 1/143 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Cardiac disorders Dressler's Syndrome	0.00% 0/140 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.70% 1/143 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
General disorders Drug Allergy	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Vascular disorders Intracranial Hemorrhage	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Injury, poisoning and procedural complications Pericardial Effusion	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Cardiac disorders Righ Atrial Lead Dislodgement	0.00% 0/140 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	1.4% 2/143 • Number of events 2 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Cardiac disorders Right Ventricular Lead Dislodgement	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Infections and infestations System Infection	0.00% 0/140 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.70% 1/143 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
Cardiac disorders Ventricular Tachycardia Requiring Emergent Direct Current Cardioversion	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.

Other adverse events

Other adverse events
Measure	Cardiac MRI Scan Group n=140 participants at risk Non-diagnostic cardiac MRI scan	Control Group n=143 participants at risk No non-diagnostic cardiac MRI scan
Cardiac disorders New Onset Paroxysmal Atrial Fibrillation	0.00% 0/140 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.70% 1/143 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.
General disorders Retracted Right Atrial Lead	0.71% 1/140 • Number of events 1 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.	0.00% 0/143 • Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected. 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.

Additional Information

Clinical Project Leader Asia

Abbott (formerly St. Jude Medical)

Phone: 0085229967605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60