THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01385202|
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Arrhythmia Atrial Fibrillation||Device: THERMOCOOL® SMARTTOUCH™ Catheter||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||May 2013|
|Experimental: THERMOCOOL® SMARTTOUCH™ Catheter||
Device: THERMOCOOL® SMARTTOUCH™ Catheter
- The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up [ Time Frame: 12-months ]The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
- Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. [ Time Frame: 7 days of the AF ablation procedure ]Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.
- Rate of Acute Success [ Time Frame: End of procedure ]Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385202
|Study Chair:||Andrea Natale, MD||Texas Cardiac Arrhythmia Research|
|Study Chair:||David J Wilber, MD||Loyola University|
|Study Chair:||Francis E Marchlinski, MD||University of Pennsylvania|
|Study Chair:||Douglas L Packer, MD||Mayo Clinic|
|Study Chair:||Hiroshi Nakagawa, MD, Ph.D.||University of Oklahoma|
|Study Chair:||Hans Kottkamp, MD||University Leipzig|