Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE SR
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
1 other identifier
interventional
39
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 atrial-fibrillation
Started Jan 2005
Longer than P75 for phase_3 atrial-fibrillation
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 3, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 25, 2012
January 1, 2012
2.9 years
December 3, 2007
January 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6 months
The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.
30 days
Secondary Outcomes (2)
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.
6 Months
The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)
Discharge
Interventions
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (10)
Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Spectrum Health
Grand Rapids, Michigan, 49506, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Washington University
St Louis, Missouri, 63110, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Sentara Norfolk Hospital
Norfolk, Virginia, 23507, United States
Sacred Heart Medical Center
Seattle, Washington, 99220, United States
St. Mary's Hospital Medical Center
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A. Marc Gillinov, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2007
First Posted
December 4, 2007
Study Start
January 1, 2005
Primary Completion
December 1, 2007
Study Completion
November 1, 2010
Last Updated
January 25, 2012
Record last verified: 2012-01