Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace (AVAIL)
Atrial Fibrillation, Congestive Heart Failure
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, AV node ablation, pacemaker, congestive heart failure
Eligibility Criteria
Inclusion Criteria: Meet the indications for therapy Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates. Eligible for AV nodal ablation and permanent pacemaker implantation NYHA Class II or III heart failure Age ≥ 18 years Understand the nature of the procedure Ability to tolerate the surgical procedure required for implantation Give informed consent Able to complete all testing required by the clinical protocol Available for follow-up visits on a regular basis at the investigational site Exclusion Criteria: Meet one or more of the contraindications Have a life expectancy of less than six months Expected to receive heart transplantation within six months Enrolled in another cardiovascular or pharmacological clinical investigation Patients with an ICD, or being considered for an ICD Patients with previously implanted biventricular pacing systems Patients with previously implanted single or dual chamber pacing system with > 50% documented ventricular pacing Patients with previous AV node ablation Six-minute walk test distance greater than 450 meters Any condition preventing the patient from being able to perform required testing Presence of another life-threatening, underlying illness separate from their cardiac disorder Conditions that prohibit placement of any of the lead systems
Sites / Locations
- University of Alabama
- Lake Charles Memorial
- Caritas St. Elizabeth's Medical Center
- St. Joseph Mercy
- McLaren Heart Foundation
- NYU Medical Center
- Aultman Hospital
- Ohio State University
- Spartanburg Regional
- Lone Star Arrhythmia
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
1
2
3
Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)