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Atrial FibrillationPhase 3RESTORE SRNCT00566787

Concomitant Treatment of Permanent Atrial Fibrillation

A Phase 3 study testing Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Type of treatment
Medical device
How many people
39 participants
Where
10 sitesUnited States
Study dates
Jan 2005to Nov 2010
Phase
Phase 3
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female subject between 18 to 80 years of age
  • Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:
  • coronary artery bypass and/or
  • mitral valve surgery (repair or replacement)
  • aortic valve surgery (repair or replacement)
  • tricuspid valve surgery (repair or replacement)
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  • Left Ventricular Ejection Fraction ≥ 30%
  • Subject is willing and able to provide written informed consent
  • Subject has a life expectancy of at least 2 years
  • Subject is willing and able to return for scheduled follow-up visits
  • TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation
  • CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery

Who cannot join

  • Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery
  • Prior cardiac surgery (Redo -including previous ablation)
  • Patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than CABG and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery
  • Serum creatinine concentration greater than 2.0 mg/dl
  • Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms
  • Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit
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  • Active infection
  • Known carotid artery stenosis greater than 80%
  • Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
  • A known drug and/or alcohol addiction
  • Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study
  • Pregnancy or desire to get pregnant within 12 months of study enrollment
  • Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Spectrum Health

    Grand Rapids, Michigan, 49506

  • The Methodist Hospital

    Houston, Texas, 77030

  • Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • St. Mary's Hospital Medical Center

    Madison, Wisconsin, 53715

  • Sentara Norfolk Hospital

    Norfolk, Virginia, 23507

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Sacred Heart Medical Center

    Seattle, Washington, 99220

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Prospective, Multi-center Study With Case Matched Controls to Evaluate the Safety and Efficacy of the AtriCure Bipolar System for the Treatment of Continuous Atrial Fibrillation as Adjunct Therapy to Elective Open Heart Surgery

RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System

Being tested
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Keywords
AF, Atrial Fibrillation, afib, racing heart, cabg, valve, ablation, bipolar, radiofrequency, rf
Medical subject headings
Atrial Fibrillation, Tachycardia

What participants receive

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

  • Surgical bipolar radiofrequency ablation using the AtriCure Bipolar SystemDevice

    Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

What is being measured

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

  1. Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit.

    Measured: 6 months

  2. The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.

    Measured: 30 days

Secondary outcomes (2)

  1. The secondary efficacy endpoint is the proportion of patients in the treatment group who are free of atrial fibrillation independent of the need for anti-arrhythmic drugs.

    Measured: 6 Months

  2. The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)

    Measured: Discharge

Timeline

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

  1. First posted4 Dec 2007 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2007
  4. Study completionNov 2010

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00566787
Sponsor's protocol ID
CP2003-1
Acronym
RESTORE SR
Status last verified
Jan 2012
First submitted
3 Dec 2007
Last updated
25 Jan 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 25 Jan 2012. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit. (time frame: 6 months). The study lists 2 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 NCT00566787.

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 25 Jan 2012.

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Concomitant Treatment of Permanent Atrial Fibrillation | AzTrials