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OpenTrials
Completed

NCT Number: NCT01677052

THERMOCOOL® SMARTTOUCH™ Registry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acute Success

    Time frame: 1 year

    Confirmation of entrance block in the pulmonary veins (acute success)

  2. Contact Force

    Time frame: 1 year

    Contact force during ablation procedures

  3. Adverse Events

    Time frame: 1 year

    Procedural complications and adverse events throughout the registry

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 31, 2012
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.