THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2018 |
| Start Date: | July 1, 2012 |
| End Date: | October 1, 2014 |
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
This is a prospective, multicenter, non-randomized continued access clinical evaluation
utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
The device is currently under investigation with IDE #G110030. This continued access study
will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug
refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this
study. Effectiveness and safety endpoints have been defined and will be evaluated post
treatment.
will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug
refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this
study. Effectiveness and safety endpoints have been defined and will be evaluated post
treatment.
Inclusion Criteria:
- Have had at least 3 atrial fibrillation episodes within 6 months of this study
- Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation
episodes
- 18 years of age or older
Exclusion Criteria including, but not limited to:
- Have had previous ablation for atrial fibrillation
- Have take amiodarone within 6 months of this study
- Have had any heart surgery within the last 60 days
- Have had a heart attack within the last 60 days
- Females who are pregnant or breast feeding
We found this trial at
20
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Florida Hospital Florida Hospital is one of the country
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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