Status:
TERMINATED
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
Lead Sponsor:
Biotronik, Inc.
Conditions:
Atrial Fibrillation
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 fibrilla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00356057
Start Date
December 1 2004
End Date
June 1 2008
Last Update
February 27 2018
Active Locations (10)
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1
University of Alabama
Birmingham, Alabama, United States
2
Lake Charles Memorial
Lake Charles, Louisiana, United States
3
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
4
St. Joseph Mercy
Ann Arbor, Michigan, United States