Back to resultsSole-Therapy Treatment of Atrial Fibrillation (RESTORE SR II)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Surgical Ablation using the AtriCure Bipolar System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, AF, AFIB, racing heart, pulmonary vein isolation, pvi, mini maze, maze
Eligibility Criteria
Inclusion Criteria:
- Male or female patient between 18 and 80 years of age
Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
- Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
- Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
- Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
- Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
- Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
- Patient is willing and able to provide written informed consent.
- Patient has a life expectancy of at least 2 years.
- Patient is willing and able to attend the scheduled follow-up visits.
- Weight < 325 lbs
Exclusion Criteria:
- Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
- Prior cardiac surgery
- Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
- Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
- Cerebrovascular accident within previous 6 months
- Known carotid artery stenosis greater than 80%
- Evidence of significant active infection
- Patient unable to undergo TEE
- Pregnant woman
- Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
- Presence of thrombus in the left atrium
- Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
- Patient is enrolled in another investigational study
Sites / Locations
- University Community Hospital/Dr. Kiran C. Patel Research Institute
- University of Cincinnati
- University of Oklahoma Cardiac Arrythmia Research Institute
- Sacred Heart Medical Center Endovascular Research
- Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
Outcomes
Primary Outcome Measures
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00566176
Brief Title
Sole-Therapy Treatment of Atrial Fibrillation
Acronym
RESTORE SR II
Official Title
Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
4. Oversight
5. Study Description
Brief Summary
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, AF, AFIB, racing heart, pulmonary vein isolation, pvi, mini maze, maze
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Surgical Ablation using the AtriCure Bipolar System
Intervention Description
Surgical Ablation using the AtriCure Bipolar System
Primary Outcome Measure Information:
Title
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
Time Frame
Perioperatively
Title
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
Time Frame
Discharge/30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient between 18 and 80 years of age
Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.
Weight < 325 lbs
Exclusion Criteria:
Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
Prior cardiac surgery
Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
Cerebrovascular accident within previous 6 months
Known carotid artery stenosis greater than 80%
Evidence of significant active infection
Patient unable to undergo TEE
Pregnant woman
Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
Presence of thrombus in the left atrium
Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
Patient is enrolled in another investigational study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Jackman, MD
Organizational Affiliation
University of Oklamhoma Cardiac Arrythmia Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Edgerton, MD
Organizational Affiliation
Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Community Hospital/Dr. Kiran C. Patel Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33616
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Oklahoma Cardiac Arrythmia Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Sacred Heart Medical Center Endovascular Research
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sole-Therapy Treatment of Atrial Fibrillation
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