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)
This study has been terminated.
(Slow enrollment.)
Sponsor:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00356057
First received: July 21, 2006
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Congestive Heart Failure |
Device: Protos DR/CLS and Stratos LV CRT pacemakers |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF |
Resource links provided by NLM:
Further study details as provided by Biotronik, Inc.:
Primary Outcome Measures:
- Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months [ Time Frame: Change from baseline to six months post-procedure ] [ Designated as safety issue: No ]Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))
- System-related Complication-free Rate [ Time Frame: at six months post-procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Improvement in 6-minute Walk Test [ Time Frame: at six months post-procedure ] [ Designated as safety issue: No ]
- Improvement in QOL Score [ Time Frame: at six months post-procedure ] [ Designated as safety issue: No ]
- Cardiac Remodeling Assessments by Echocardiography [ Time Frame: at six months post-procedure ] [ Designated as safety issue: No ]
- Changes in NYHA Classification [ Time Frame: at six months post-procedure ] [ Designated as safety issue: No ]
- Rate of CHF Hospitalizations and Total Mortality [ Time Frame: at six months post-procedure ] [ Designated as safety issue: No ]
| Enrollment: | 153 |
| Study Start Date: | December 2004 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
|
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
Other Name: Protos DR/CLS dual chamber pacemaker
|
|
Active Comparator: 2
Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
|
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
Other Name: Protos DR/CLS dual chamber pacemaker
|
|
Active Comparator: 3
Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
|
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
Other Name: Protos DR/CLS dual chamber pacemaker
|
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 i.e. "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 2:2:1. Patients will be assigned to receive either biventricular (biV) pacing with CLS-based rate adaptive pacing using the legally marketed Protos DR/CLS (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356057
Locations
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States | |
| United States, Louisiana | |
| Lake Charles Memorial | |
| Lake Charles, Louisiana, United States | |
| United States, Massachusetts | |
| Caritas St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| St. Joseph Mercy | |
| Ann Arbor, Michigan, United States | |
| McLaren Heart Foundation | |
| LaPeer, Michigan, United States | |
| United States, New York | |
| NYU Medical Center | |
| New York, New York, United States | |
| United States, Ohio | |
| Aultman Hospital | |
| Canton, Ohio, United States | |
| Ohio State University | |
| Columbus, Ohio, United States | |
| United States, South Carolina | |
| Spartanburg Regional | |
| Spartanburg, South Carolina, United States | |
| United States, Texas | |
| Lone Star Arrhythmia | |
| Amarillo, Texas, United States | |
Sponsors and Collaborators
Biotronik, Inc.
Investigators
| Principal Investigator: | Michael Orlov, MD | Caritas Elizabeth, Boston, MA |
More Information
No publications provided
| Responsible Party: | Biotronik, Inc. |
| ClinicalTrials.gov Identifier: | NCT00356057 History of Changes |
| Other Study ID Numbers: | G040150 |
| Study First Received: | July 21, 2006 |
| Results First Received: | December 2, 2008 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biotronik, Inc.:
|
atrial fibrillation AV node ablation pacemaker congestive heart failure |
Additional relevant MeSH terms:
|
Atrial Fibrillation Heart Failure Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013