Back to resultsInvestigational 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)
Primary Purpose
Atrial Fibrillation, Congestive Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protos DR/CLS and Stratos LV CRT pacemakers
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, AV node ablation, pacemaker, congestive heart failure
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
Sites / Locations
- University of Alabama
- Lake Charles Memorial
- Caritas St. Elizabeth's Medical Center
- St. Joseph Mercy
- McLaren Heart Foundation
- NYU Medical Center
- Aultman Hospital
- Ohio State University
- Spartanburg Regional
- Lone Star Arrhythmia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Outcomes
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
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))
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.
Secondary Outcome Measures
Change in Six-minute Walk Test
Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months
Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. This outcome was calculated as QOL score at baseline minus QOL score at 6 months. Therefore, a positive change in QOL score represents an improvement in quality of life, while a negative change in QOL score represents a worsening.
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction
Changes in New York Heart Association (NYHA) Classification
The purpose is to evaluate the change in the participant's NYHA classification.
There are four NYHA classes:
Class I: Patients with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations
Mortality Rate
Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356057
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
Acronym
AVAIL
Official Title
AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment.
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Congestive Heart Failure
Keywords
atrial fibrillation, AV node ablation, pacemaker, congestive heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Intervention Type
Device
Intervention Name(s)
Protos DR/CLS and Stratos LV CRT pacemakers
Other Intervention Name(s)
Protos DR/CLS dual chamber pacemaker
Intervention Description
Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
Primary Outcome Measure Information:
Title
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
Description
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))
Time Frame
Change from baseline to six months post-procedure
Title
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Description
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.
Time Frame
At six months post-procedure
Title
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Description
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.
Time Frame
At six months post-procedure
Secondary Outcome Measure Information:
Title
Change in Six-minute Walk Test
Time Frame
Change from baseline to 6 months post-procedure
Title
Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months
Description
Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. This outcome was calculated as QOL score at baseline minus QOL score at 6 months. Therefore, a positive change in QOL score represents an improvement in quality of life, while a negative change in QOL score represents a worsening.
Time Frame
Change from baseline to six months post-procedure
Title
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction
Time Frame
Change from baseline to six months post-procedure
Title
Changes in New York Heart Association (NYHA) Classification
Description
The purpose is to evaluate the change in the participant's NYHA classification.
There are four NYHA classes:
Class I: Patients with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
Change from baseline to six months post-procedure
Title
Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations
Time Frame
At six months post-procedure
Title
Mortality Rate
Time Frame
At six months post-procedure
Title
Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume
Time Frame
Change from baseline to six months post-procedure
Title
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass
Time Frame
Change from baseline to six months post-procedure
Title
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume
Time Frame
Change from baseline to six months post-procedure
Title
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume
Time Frame
Change from baseline to six months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Orlov, MD
Organizational Affiliation
Caritas Elizabeth, Boston, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Lake Charles Memorial
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
St. Joseph Mercy
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
McLaren Heart Foundation
City
Lapeer
State/Province
Michigan
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Spartanburg Regional
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Lone Star Arrhythmia
City
Amarillo
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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