- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034852
Efficacy Study for Surgery After Previous Failed Catheter Ablation (SAVED)
Surgery After Previous Failed Catheter Ablation
Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.
Primary Objectives:
- Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF
- Record and evaluate all complications associated with the surgical procedure.
Secondary Objectives:
- Evaluate usage of anticoagulants at 6, and 12 months.
- Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Oregon
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Springfield, Oregon, United States, 97477
- Endovascular Research
-
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Texas
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Dallas, Texas, United States, 75230
- Cardiopulmonary Research Science and Technology Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of atrial fibrillation
- Has undergone one or more catheter based ablation procedures for AF and the procedure failed
- Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical ablation
Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation
|
Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF.
Time Frame: 1 year post operatively
|
1 year post operatively
|
Record and evaluate all complications associated with the surgical procedure.
Time Frame: 1 year post operatively
|
1 year post operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate usage of anticoagulants at 6 and 12 months.
Time Frame: 1 year post operatively
|
1 year post operatively
|
Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.
Time Frame: 1 year post operatively
|
1 year post operatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: James R Edgerton, MD, Cardiopulmonary Research Science and Technology Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.018
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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