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

NATerminatedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

May 31, 2008

Study Completion Date

June 30, 2008

Conditions
Atrial FibrillationCongestive Heart Failure
Interventions
DEVICE

Protos DR/CLS and Stratos LV CRT pacemakers

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

Trial Locations (10)

Unknown

University of Alabama, Birmingham

Lake Charles Memorial, Lake Charles

Caritas St. Elizabeth's Medical Center, Boston

St. Joseph Mercy, Ann Arbor

McLaren Heart Foundation, Lapeer

NYU Medical Center, New York

Aultman Hospital, Canton

Ohio State University, Columbus

Spartanburg Regional, Spartanburg

Lone Star Arrhythmia, Amarillo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik, Inc.

INDUSTRY