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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hopital 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
        • Charité 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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