Back to resultsAtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB (RESTORE SR IIB)
Primary Purpose
Atrial Fibrillation
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AtriCure Bipolar System
Sponsored by
About this trial
This is an interventional trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patient between 18 and 80 years of age
Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.
- Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.
- Longstanding AF: Persistent AF of 12 months (or longer) duration.
- Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.
- 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.
Exclusion Criteria:
- Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
- Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
- Myocardial infarction within 8 weeks.
- Prior cardiac surgery.
- Patient requires cardiac surgery for treatment other than for AF.
- Class IV NYHA heart failure symptoms, unless 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
- Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
- Presence of thrombus in the left atrium
- 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 cardiac clinical trial
- Left ventricular ejection fraction < 30%
- Left atrial transverse diameter >6.0
- Patient has undergone previous thoracic targeted radiation
Sites / Locations
Outcomes
Primary Outcome Measures
Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions.
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
NCT00571779
Brief Title
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
Acronym
RESTORE SR IIB
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 2011
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AtriCure, Inc.
4. Oversight
5. Study Description
Brief Summary
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
AtriCure Bipolar System
Primary Outcome Measure Information:
Title
Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions.
Title
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
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:
Patient between 18 and 80 years of age
Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.
Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.
Longstanding AF: Persistent AF of 12 months (or longer) duration.
Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.
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.
Exclusion Criteria:
Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
Myocardial infarction within 8 weeks.
Prior cardiac surgery.
Patient requires cardiac surgery for treatment other than for AF.
Class IV NYHA heart failure symptoms, unless 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
Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
Presence of thrombus in the left atrium
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 cardiac clinical trial
Left ventricular ejection fraction < 30%
Left atrial transverse diameter >6.0
Patient has undergone previous thoracic targeted radiation
12. IPD Sharing Statement
Learn more about this trial
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
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