- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571779
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB (RESTORE SR IIB)
February 18, 2011 updated by: AtriCure, Inc.
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
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
December 10, 2007
First Submitted That Met QC Criteria
December 10, 2007
First Posted (Estimate)
December 12, 2007
Study Record Updates
Last Update Posted (Estimate)
February 21, 2011
Last Update Submitted That Met QC Criteria
February 18, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP2007-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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