Clinical trial NCT01385202: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Official title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Diseases
Arrhythmia
Atrial Fibrillation
Keywords: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12-months
measure: Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
timeFrame: 7 days of the AF ablation procedure
Secondary outcomes:
measure: Rate of Acute Success
timeFrame: End of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Texas Cardiac Arrhythmia Research
name: Andrea Natale, MD
role: STUDY_CHAIR
affiliation: Loyola University
name: David J Wilber, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Francis E Marchlinski, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Douglas L Packer, MD
role: STUDY_CHAIR
affiliation: University of Oklahoma
name: Hiroshi Nakagawa, MD, Ph.D.
role: STUDY_CHAIR
affiliation: University Leipzig
name: Hans Kottkamp, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.