SyncAV Post-Market Trial

Prior treatment

• Recent myocardial infarction or unstable angina within 40 days prior to signing consent
• Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
• Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
• 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
• Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
• Prior CRT device implant
• Prior His Bundle pacing implant or plan to have His Bundle pacing implant
• 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

Other illness

• Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
• Life expectancy \< 12 months due to any condition

Other

• Permanent or persistent AF at the time of signing consent
• Pregnant or breastfeeding at the time of signing consent
• Incapacitated or unable to read or write
• Unavailable for at least 12 months of follow-up visits

• 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:
  • 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
  • LVEF ≤ 35% based on a prior standard of care echocardiogram
  • Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,
  • 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)
• At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
• Willing and able to comply with the prescribed follow-up tests and schedule of evaluations