The SyncAV Post-Market Trial will evaluate changes in LV end-systolic volume (LVESV) between baseline (before CRT implant) and 12 months (post-randomization) in patients with CRT devices programmed with SyncAV compared to patients with CRT devices…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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
follow-up 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.
Background summary
Cardiac resynchronization therapy (CRT) reduces mortality and hospitalizations
for patients with heart failure, impaired LV function, and a wide QRS complex.
Although the majority of patients benefit from CRT, approximately 30-40% of
patients are classified as non-responders. The cause of non-response is
multi-factorial and may be due in part to suboptimal LV lead placement and LV
electrical activation.
CRT optimization to obtain ideal electrical resynchronization may improve
response. This demands individualized device programming as changes in LV
function at different programmed settings can affect resynchronization.
Numerous methods exist to achieve optimal CRT device programming, however,
there is no consensus on the value of systematic optimization in all patients.
Traditionally, clinicians have used echocardiography and/or invasive LV
pressure to identify the best programming parameters, but both are costly,
require exhaustive, iterative sampling, and often must occur in clinic or in a
catherization laboratory. In addition, both optimization methods have failed in
leading to improved clinical outcomes compared to nominal device settings.
Electrocardiographic optimization is another widely used method to determine
optimal CRT programming parameters. One specific method aims to fuse intrinsic
conduction with RV and LV paced wave fronts with the goal of minimizing the QRS
duration. Recent studies demonstrate that achieving these fusion optimized
intervals results in superior clinical outcomes. Electrocardiographic
optimization can also be accomplished through automatic, device-based
algorithms utilizing intracardiac electrograms, which have obvious practical
advantages compared to other methods. However, results from trials utilizing
this technology have failed to demonstrate significant clinical improvement
compared to more conventional optimization protocols. In the Smart-AV trial,
AV optimization using a device-based algorithm did not lead to improved LV
reverse remodeling compared to nominal device settings. Likewise, the Adaptive
CRT trial showed that the device-based algorithm was non-inferior to
echocardiographic optimization in CRT response based on the Clinical Composite
Score (CCS).
These device-based algorithms may be limited due to their ability to only
deliver a one-time, static, in-clinic CRT optimization, as this may not
accommodate the daily range of cardiovascular conditions patients may exhibit.
Truly effective optimization must frequently occur, if not continually, in all
ambulatory conditions for CRT to fully adapt to the distinct cardiovascular
dynamics of each patient.
Study objective
The SyncAV Post-Market Trial will evaluate changes in LV end-systolic volume
(LVESV) between baseline (before CRT implant) and 12 months
(post-randomization) in patients with CRT devices programmed with SyncAV
compared to patients with CRT devices programmed with a fixed AV delay.
Study design
The SyncAV Post-Market Trial is a prospective, randomized, multi-center
clinical trial designed to evaluate the impact of programming CRT devices using
SyncAV on LV reverse remodeling compared with programming CRT devices using
conventional CRT settings with a fixed AV delay.
Study burden and risks
No additional risk is associated with participation in the clinical trial. The
burden will consist of filling out questionnaires at the follow up visits.
And for the subjects in the SyncAV group the extra time needed for optimization
during the programming of the device.
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Listed location countries
Age
Inclusion criteria
Subjects must meet the following inclusion criteria for enrollment in the
clinical trial.
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% 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% 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
Exclusion criteria
Subjects will be excluded from enrollment if they meet any of the below
exclusion 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 a 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73054.099.20 |