THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
NCT ID: NCT01385202
Last Updated: 2025-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
172 participants
INTERVENTIONAL
2011-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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THERMOCOOL® SMARTTOUCH™ Catheter
THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation
Interventions
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THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation
Eligibility Criteria
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Inclusion Criteria
* Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
* 18 years of age or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Natale, MD
Role: STUDY_CHAIR
Texas Cardiac Arrhythmia Research
David J Wilber, MD
Role: STUDY_CHAIR
Loyola University
Francis E Marchlinski, MD
Role: STUDY_CHAIR
University of Pennsylvania
Douglas L Packer, MD
Role: STUDY_CHAIR
Mayo Clinic
Hiroshi Nakagawa, MD, Ph.D.
Role: STUDY_CHAIR
University of Oklahoma
Hans Kottkamp, MD
Role: STUDY_CHAIR
University Leipzig
References
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Reddy VY, Pollak S, Lindsay BD, McElderry HT, Natale A, Kantipudi C, Mansour M, Melby DP, Lakkireddy D, Levy T, Izraeli D, Sangli C, Wilber D. Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016 Nov;2(6):691-699. doi: 10.1016/j.jacep.2016.07.014. Epub 2016 Nov 21.
Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
Other Identifiers
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Smart-AF
Identifier Type: -
Identifier Source: org_study_id
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