THERMOCOOL® SMARTTOUCH™ Registry

January 31, 2025 updated by: Biosense Webster, Inc.

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

The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

426

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • St. Andrew's Hospital
      • Adelaide, Australia, 5000
        • The Prince Charles Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • University of Adelaide/Royal Adelaide Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Melbourne Health/Royal Melbourne Hospital
  • Belgium
      • Aalst, Belgium, 9300
        • OLV Hospital Aalst Cardiovascular Center
      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, 1090-B
        • UZ Brussel
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg, Genk
  • Canada
      • Quebec, Canada, G1V 4G5
        • Hôpital Laval
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
  • France
      • Le Chesnay, France, 78150
        • Clinique Hopital Prive de Parly II
      • Toulouse Cedex, France, 50032
        • CHU Rangueil Toulouse
      • Villeurbanne, France, 69100
        • Clinique Infirmerie Protestante
  • Germany
      • Bad Neustadt, Germany, 97616
        • Herz-und GefaB-Klinik, Bad Neustadt
      • Berlin, Germany, 10117
        • Charite Campus Mitte
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin-Buch
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Munich, Germany, 80539
        • Ludwig Maximilian University of Munich
  • Italy
      • Acquaviva delle Fonti, Italy, 70021
        • Ospedale Miulli
      • Cirie (TO), Italy
        • ASL no. 6
      • Lecco, Italy, 23900
        • Ospedale Manzoni di Lecco
      • Massa, Italy, 54100
        • Giacomo and Cristoforo Hospital
  • Monaco
      • Monte Carlo, Monaco, 98000
        • CH Princesse Grace
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Heart Institute
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital, Leicester
      • London, United Kingdom, SE1 7EH
        • St. Thomas' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Target enrollment for this registry is 650 subjects. Of the 650 subjects enrolled, at least 250 will have paroxysmal atrial fibrillation.

Description

Inclusion Criteria:

  • Subjects with symptomatic atrial fibrillation (AF) who, in the opinion of the investigator, are candidates for ablation for atrial fibrillation. Candidates who have had previous ablation procedures may be included in the registry
  • Subjects who have failed at least one antiarrhythmic drug (AAD)(class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic atrial fibrillation, or intolerable to the AAD.
  • Subjects must be 18 years of age or older
  • Subjects must be able and willing to comply with all pre-, post and follow-up testing and requirements
  • Subjects must provide written informed consent to participate in the registry

Exclusion Criteria:

  • Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this registry
  • History of blood clotting or bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
  • History of a documented thromboembolic event within the past year
  • Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease)or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
  • Previous cardiac surgery (eg, CABG) or valvular cardiac surgical procedure (eg, ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic valve)
  • Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months)
  • Diagnosed atrial myxoma
  • Unstable angina
  • Uncontrolled heart failure Uncontrolled heart Failure or NYHA Class III or IV heart failure
  • Acute illness, active systemic infection, or sepsis
  • Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Success
Time Frame: 1 year
Confirmation of entrance block in the pulmonary veins (acute success)
1 year
Contact Force
Time Frame: 1 year
Contact force during ablation procedures
1 year
Adverse Events
Time Frame: 1 year
Procedural complications and adverse events throughout the registry
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimated)

August 31, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR-148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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