THERMOCOOL® SMARTTOUCH™ Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01677052
First received: August 29, 2012
Last updated: February 27, 2014
Last verified: February 2014

August 29, 2012
February 27, 2014
August 2012
August 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01677052 on ClinicalTrials.gov Archive Site
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THERMOCOOL® SMARTTOUCH™ Registry
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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

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

Symptomatic Atrial Fibrillation
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
650
February 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Monaco,   United Kingdom
 
NCT01677052
STR-148
Yes
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Not Provided
Biosense Webster, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP