Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356057
Status:
TERMINATED
Last Update Posted:
2018-02-27
First Post:
2006-07-21
Brief Title:
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
Sponsor:
Biotronik Inc
Organization:
Biotronik Inc
Study Overview
Official Title:
AVAIL CLSCRT AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVAIL
Brief Summary:
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
Detailed Description:
This study is a multi-center prospective randomized blinded trial The study will consist of approximately 265 patients who require treatment of persistent or permanent symptomatic atrial fibrillation by atrioventricular AV node ablation and permanent pacing therapy ie Ablate and Pace therapy All patients enrolled into the clinical study will be randomly assigned to one of three groups using a randomization ratio of 221 Patients will be assigned to receive either biventricular biV pacing with CLS-based rate adaptive pacing using the legally marketed Protos DRCLS Group 1 or biventricular pacing with accelerometer-based rate adaptive pacing using the Stratos LV Group 2 or right ventricular RV pacing with accelerometer-based rate adaptive pacing using the Stratos LV Group 3 Patients in all three groups will be implanted with legally marketed right and left ventricular pacing leads The patients the core lab used to interpret the echocardiographic data and the Clinical Events Committee adjudicating crossover patient death and congestive heart failure CHF hospitalizations will be blinded to the randomization assignment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None