Clinical trial NCT00356057: 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
Official title: AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Congestive Heart Failure
Keywords: atrial fibrillation
AV node ablation
pacemaker
congestive heart failure
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2006-07-25
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: 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
timeFrame: Change from baseline to six months post-procedure
measure: Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
timeFrame: At six months post-procedure
measure: Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
timeFrame: At six months post-procedure
Secondary outcomes:
measure: Change in Six-minute Walk Test
timeFrame: Change from baseline to 6 months post-procedure
measure: Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months
timeFrame: Change from baseline to six months post-procedure
measure: Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction
timeFrame: Change from baseline to six months post-procedure
measure: Changes in New York Heart Association (NYHA) Classification
timeFrame: Change from baseline to six months post-procedure
measure: Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations
timeFrame: At six months post-procedure
measure: Mortality Rate
timeFrame: At six months post-procedure
measure: Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume
timeFrame: Change from baseline to six months post-procedure
measure: Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass
timeFrame: Change from baseline to six months post-procedure
measure: Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume
timeFrame: Change from baseline to six months post-procedure
measure: Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume
timeFrame: Change from baseline to six months post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Lake Charles
country: United States
facility: Lake Charles Memorial
state: Louisiana
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy
state: Michigan
city: Lapeer
country: United States
facility: McLaren Heart Foundation
state: Michigan
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional
state: South Carolina
city: Amarillo
country: United States
facility: Lone Star Arrhythmia
state: Texas
Study officials:
affiliation: Caritas Elizabeth, Boston, MA
name: Michael Orlov, MD
role: PRINCIPAL_INVESTIGATOR
References: