Trial Outcomes & Findings for Restoration of Atrioventricular Synchrony Trial (NCT NCT01275833)

NCT ID: NCT01275833

Last Updated: 2017-06-26

Results Overview

Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-06-26

Participant Flow

Participant milestones

Measure	Device Programming That Modifies AV Timing Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing	Device Programming That Allows Intrinsic AV Timing. Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Device Programming That Modifies AV Timing Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing	Device Programming That Allows Intrinsic AV Timing. Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
Overall Study Study terminated	1	1

Baseline Characteristics

Restoration of Atrioventricular Synchrony Trial

Baseline characteristics by cohort

Measure	Device Programming Modifies AV Timing n=1 Participants DDD-40-BiV Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing	Device Programming Allows Intrinsic AV Timing. n=1 Participants VVI-40-RV	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The study was terminated early: long PR intervals are relatively rare in this population, and it would take an inordinately long time to enroll sufficient patients. Because of the early termination of the study, no data was analyzed since the primary objective is underpowered.

Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.

Outcome measures

Measure	Device Programming That Modifies AV Timing Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing	Device Programming That Allows Intrinsic AV Timing. Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.	0	0

Adverse Events

Device Programming That Modifies AV Timing

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Device Programming That Allows Intrinsic AV Timing.

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Device Programming That Modifies AV Timing n=1 participants at risk Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing	Device Programming That Allows Intrinsic AV Timing. n=1 participants at risk Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
Cardiac disorders Sarcoidosis induced cardiomyopathy	100.0% 1/1 • Number of events 2 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Eye disorders Cataract surgery	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.

Other adverse events

Measure	Device Programming That Modifies AV Timing n=1 participants at risk Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing	Device Programming That Allows Intrinsic AV Timing. n=1 participants at risk Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
Cardiac disorders Prolonged hospitalization due to sarcoidosis induced cardiomyopathy	100.0% 1/1 • Number of events 1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Ventricular tachycardia	100.0% 1/1 • Number of events 1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Ear and labyrinth disorders Dizziness	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.	100.0% 1/1 • Number of events 1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Non-sustained ventricular tachycardia	0.00% 0/1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.	100.0% 1/1 • Number of events 1 • Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit). An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.

Additional Information

Elke Sommerijns

Boston Scientific

Phone: +32479767156

Email: elke.sommerijns@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place