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

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation, Congestive Heart Failure

In brief

The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.

Key facts

Study ID

NCT00356057

Run by

Biotronik, Inc.

People needed

153

Starts

2004-12-01

Expected to finish

2008-06-01

Last updated by the study team

2018-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Lake Charles Memorial — Lake Charles, Louisiana, United States
• Caritas St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• St. Joseph Mercy — Ann Arbor, Michigan, United States
• McLaren Heart Foundation — Lapeer, Michigan, United States
• NYU Medical Center — New York, New York, United States
• Aultman Hospital — Canton, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Spartanburg Regional — Spartanburg, South Carolina, United States
• Lone Star Arrhythmia — Amarillo, Texas, United States

Full record on ClinicalTrials.gov

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