THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01385202
First received: June 27, 2011
Last updated: January 20, 2015
Last verified: January 2015
  Purpose

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.


Condition Intervention Phase
Heart Diseases
Arrhythmia
Atrial Fibrillation
Device: THERMOCOOL® SMARTTOUCH™ Catheter
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Rate of Acute Success [ Time Frame: End of procedure ] [ Designated as safety issue: No ]
    Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).


Enrollment: 172
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THERMOCOOL® SMARTTOUCH™ Catheter Device: THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385202

  Show 23 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
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
  More Information

No publications provided by Biosense Webster, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01385202     History of Changes
Other Study ID Numbers: Smart-AF
Study First Received: June 27, 2011
Results First Received: December 17, 2014
Last Updated: January 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 26, 2015