NCT01385202

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

June 27, 2011

Results QC Date

December 17, 2014

Last Update Submit

January 31, 2025

Conditions

Heart DiseasesArrhythmiaAtrial Fibrillation

Keywords

Atrial FibrillationParoxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    12-months

  • Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.

    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.

    7 days of the AF ablation procedure

Secondary Outcomes (1)

  • Rate of Acute Success

    End of procedure

Study Arms (1)

THERMOCOOL® SMARTTOUCH™ Catheter

EXPERIMENTAL
Device: THERMOCOOL® SMARTTOUCH™ Catheter

Interventions

THERMOCOOL® SMARTTOUCH™ CatheterDEVICE

AF Ablation

THERMOCOOL® SMARTTOUCH™ Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29759747DERIVED

  • 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.

    PMID: 25125294DERIVED

MeSH Terms

Conditions

Heart DiseasesArrhythmias, CardiacAtrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Robert Stagg, Manager, Clinical Operations
Organization
Biosense Webster, Inc.
RStagg@its.jnj.com
(800) 729-9010

Study Officials

  • 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

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

February 4, 2025

Results First Posted

January 26, 2015

Record last verified: 2025-01