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Atrial FibrillationAVAILNCT00356057

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

A study testing Protos DR/CLS and Stratos LV CRT pacemakers in people with Atrial Fibrillation and Congestive Heart Failure, run by Biotronik, Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Congestive Heart Failure
What is being tested?
Protos DR/CLS and Stratos LV CRT pacemakers
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
10 sitesUnited States
Study dates
Dec 2004to Jun 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Lone Star Arrhythmia

    Amarillo, Texas

  • St. Joseph Mercy

    Ann Arbor, Michigan

  • University of Alabama

    Birmingham, Alabama

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts

  • Aultman Hospital

    Canton, Ohio

  • Ohio State University

    Columbus, Ohio

  • Lake Charles Memorial

    Lake Charles, Louisiana

  • McLaren Heart Foundation

    Lapeer, Michigan

  • NYU Medical Center

    New York, New York

  • Spartanburg Regional

    Spartanburg, South Carolina

Other trials in United States

About this study

Official title: AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF

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.

Read the 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.

Being tested
Protos DR/CLS and Stratos LV CRT pacemakers
Keywords
atrial fibrillation, AV node ablation, pacemaker, congestive heart failure
Medical subject headings
Atrial Fibrillation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protos DR/CLS and Stratos LV CRT pacemakersDevice

    Also called Protos DR/CLS dual chamber pacemaker

    Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

Study groups in NCT00356057
Study groupRoleWhat they receive
1Active comparatorBiventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
Receives: Device: Protos DR/CLS and Stratos LV CRT pacemakers
2Active comparatorBiventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Receives: Device: Protos DR/CLS and Stratos LV CRT pacemakers
3Active comparatorRight Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
Receives: Device: Protos DR/CLS and Stratos LV CRT pacemakers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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))

    Measured: Change from baseline to six months post-procedure

  2. 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.

    Measured: At six months post-procedure

  3. 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.

    Measured: At six months post-procedure

Secondary outcomes (10)

  1. Change in Six-minute Walk Test

    Measured: Change from baseline to 6 months post-procedure

  2. 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.

    Measured: Change from baseline to six months post-procedure

  3. Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction

    Measured: Change from baseline to six months post-procedure

  4. 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.

    Measured: Change from baseline to six months post-procedure

  5. Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations

    Measured: At six months post-procedure

  6. Mortality Rate

    Measured: At six months post-procedure

  7. Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume

    Measured: Change from baseline to six months post-procedure

  8. Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass

    Measured: Change from baseline to six months post-procedure

  9. Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume

    Measured: Change from baseline to six months post-procedure

  10. Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume

    Measured: Change from baseline to six months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2006 (estimated)
  2. Study startDec 2004
  3. Primary completionMay 2008
  4. Study completionJun 2008

Why it stopped: Slow enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356057
Sponsor's protocol ID
G040150
Acronym
AVAIL
Status last verified
Jan 2018
First submitted
21 Jul 2006
Last updated
27 Feb 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Protos DR/CLS and Stratos LV CRT pacemakers in people with Atrial Fibrillation and Congestive Heart Failure, run by Biotronik, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Change from baseline to six months post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.

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