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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Australia, South Australia
University of Adelaide/Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne Health/Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia
St. Andrew's Hospital
Adelaide, Australia, 5000
The Prince Charles Hospital
Adelaide, Australia, 5000
Belgium
OLV Hospital Aalst Cardiovascular Center
Aalst, Belgium, 9300
UZ Brussel
Brussels, Belgium, 1090-B
CHU Brugmann
Brussels, Belgium, 1020
Ziekenhuis Oost-Limburg, Genk
Genk, Belgium, 3600
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada
Hopital Laval
Quebec, Canada, G1V 4G5
France
Clinique Hopital Prive de Parly II
Le Chesnay, France, 78150
CHU Rangueil Toulouse
Toulouse Cedex, France, 50032
Clinique Infirmerie Protestante
Villeurbanne, France, 69100
Germany
Herz-und GefaB-Klinik, Bad Neustadt
Bad Neustadt, Germany, 97616
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125
Charite Campus Mitte
Berlin, Germany, 10117
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Ludwig Maximilian University of Munich
Munich, Germany, 80539
Italy
Ospedale Miulli
Acquaviva delle Fonti, Italy, 70021
ASL no. 6
Cirie (TO), Italy
Ospedale Manzoni di Lecco
Lecco, Italy, 23900
Giacomo and Cristoforo Hospital
Massa, Italy, 54100
Monaco
CH Princesse Grace
Monte Carlo, Monaco, 98000
United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Bristol Heart Institute
Bristol, United Kingdom, BS2 8HW
Papworth Hospital
Cambridge, United Kingdom, CB23 3RE
Glenfield Hospital, Leicester
Leicester, United Kingdom, LE3 9QP
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
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: February 27, 2014
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 July 22, 2014