- ICH GCP
- US Clinical Trials Registry
- 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 (AVAIL)
AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States
- University of Alabama
-
-
Louisiana
-
Lake Charles, Louisiana, United States
- Lake Charles Memorial
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Caritas St. Elizabeth's Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, United States
- St. Joseph Mercy
-
Lapeer, Michigan, United States
- McLaren Heart Foundation
-
-
New York
-
New York, New York, United States
- NYU Medical Center
-
-
Ohio
-
Canton, Ohio, United States
- Aultman Hospital
-
Columbus, Ohio, United States
- Ohio State University
-
-
South Carolina
-
Spartanburg, South Carolina, United States
- Spartanburg Regional
-
-
Texas
-
Amarillo, Texas, United States
- Lone Star Arrhythmia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
|
Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
Other Names:
|
ACTIVE_COMPARATOR: 2
Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
|
Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
Other Names:
|
ACTIVE_COMPARATOR: 3
Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
|
Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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))
|
Change from baseline to six months post-procedure
|
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Time Frame: At six 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.
|
At six months post-procedure
|
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Time Frame: At six 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.
|
At six months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Six-minute Walk Test
Time Frame: Change from baseline to 6 months post-procedure
|
Change from baseline to 6 months post-procedure
|
|
Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months
Time Frame: Change from baseline to six months post-procedure
|
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.
|
Change from baseline to six months post-procedure
|
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction
Time Frame: Change from baseline to six months post-procedure
|
Change from baseline to six months post-procedure
|
|
Changes in New York Heart Association (NYHA) Classification
Time Frame: Change from baseline to six months post-procedure
|
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. |
Change from baseline to six months post-procedure
|
Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations
Time Frame: At six months post-procedure
|
At six months post-procedure
|
|
Mortality Rate
Time Frame: At six months post-procedure
|
At six months post-procedure
|
|
Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume
Time Frame: Change from baseline to six months post-procedure
|
Change from baseline to six months post-procedure
|
|
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass
Time Frame: Change from baseline to six months post-procedure
|
Change from baseline to six months post-procedure
|
|
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume
Time Frame: Change from baseline to six months post-procedure
|
Change from baseline to six months post-procedure
|
|
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume
Time Frame: Change from baseline to six months post-procedure
|
Change from baseline to six months post-procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Orlov, MD, Caritas Elizabeth, Boston, MA
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G040150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Protos DR/CLS and Stratos LV CRT pacemakers
-
Biotronik SE & Co. KGCompleted