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Completed

NCT Number: NCT00566787

Concomitant Treatment of Permanent Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Center of Indiana, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Device

Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Primary outcomes

  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.

    Time frame: 6 months

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

    Time frame: 30 days

Secondary outcomes

  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.

    Time frame: 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)

    Time frame: Discharge

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study 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

Acronym: RESTORE SR

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
Dec 4, 2007
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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