SyncAV Post-Market Trial

JRCT ID: jRCT1032200183

Registered date:06/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Congestive Heart Failure
• Date of first enrollment: 01/01/2021
• Target sample size: 1400
• Countries of recruitment: USA,Japan,India,Japan,Portugal,Japan,South Korea,Japan,Spain,Japan,Canada,Japan,Italy,Japan,Saudi Arabia,Japan,Singapore,Japan,Sweden,Japan,Australia,Japan,Belgium,Japan,China,Japan,Columbia,Japan,Finland,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Poland,Japan,Portugal,Japan,Puertorico,Japan,Russia,Japan,Serbia,Japan,Switzerlad,Japan,Taiwan,Japan,UAE,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

<Device: SyncAV programmed ON>
For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.

<Device: Fixed AV delay>
For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.

Outcome(s)

• Primary Outcome: The primary endpoint of this trial will be evaluated at 12 months following trial randomization and is defined as the reduction of left ventricular end-systolic volume (LVESV) as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.

Secondary Outcome

One powered secondary endpoint will be evaluated at 12 months following trial randomization and is defined as:
- Percentage of subjects classified as CRT responders after 12 months of followup compared between subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline. Subjects who died due to cardiovascular cause post randomization will be classified as non-responders.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10 percent RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria
a.Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist
b.LVEF =< 35 percent based on a prior standard of care echocardiogram
c.Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,
i. QRS duration >= 120 ms
ii. QS or rS pattern in leads V1
iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval =< 280 ms on surface ECG)
2.At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
3.Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclude criteria

1.Recent myocardial infarction or unstable angina within 40 days prior to signing consent
2.Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
3.Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
4.Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent
5.Permanent or persistent AF at the time of signing consent
6.Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
7.Prior CRT device implant
8.Prior His Bundle pacing implant or plan to have His Bundle pacing implant
9.Pregnant or breastfeeding at the time of signing consent
10.Incapacitated or unable to read or write
11.Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
12.Life expectancy < 12 months due to any condition
13.Unavailable for at least 12 months of follow-up visits
14.Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott

Related Information

• Primary Sponsor: Kulkarni Anuja
• Secondary ID(s): NCT04100148