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THERMOCOOL® SMARTTOUCH™ Registry

This study is currently recruiting participants.
Verified June 2013 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01677052
First received: August 29, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition
Symptomatic Atrial Fibrillation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Acute Success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Confirmation of entrance block in the pulmonary veins (acute success)

  • Contact Force [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Contact force during ablation procedures

  • Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Procedural complications and adverse events throughout the registry


Estimated Enrollment: 650
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677052

Contacts
Contact: Chris Hendricks (909) 839-8500
Contact: Francis Villanueva (909) 839-8500

  Show 30 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01677052     History of Changes
Other Study ID Numbers: STR-148
Study First Received: August 29, 2012
Last Updated: June 3, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013