Cardiac arrhythmias Cardiac resynchronisation therapy
Conditions
Interventions
None listed
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 = 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed