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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01677052




Registration number
NCT01677052
Ethics application status
Date submitted
29/08/2012
Date registered
31/08/2012
Date last updated
25/09/2014

Titles & IDs
Public title
THERMOCOOL® SMARTTOUCH™ Registry
Scientific title
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry
Secondary ID [1] 0 0
STR-148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute Success
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Contact Force
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0
1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
426
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
University of Adelaide/Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Melbourne Health/Royal Melbourne Hospital - Parkville
Recruitment hospital [3] 0 0
St. Andrew's Hospital - Adelaide
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
France
State/province [6] 0 0
Le Chesnay
Country [7] 0 0
France
State/province [7] 0 0
Toulouse Cedex
Country [8] 0 0
France
State/province [8] 0 0
Villeurbanne
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Neustadt
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Munich
Country [13] 0 0
Italy
State/province [13] 0 0
Acquaviva delle Fonti
Country [14] 0 0
Italy
State/province [14] 0 0
Cirie (TO)
Country [15] 0 0
Italy
State/province [15] 0 0
Lecco
Country [16] 0 0
Italy
State/province [16] 0 0
Massa
Country [17] 0 0
Monaco
State/province [17] 0 0
Monte Carlo
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Bournemouth
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Bristol
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Cambridge
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Leicester
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biosense Webster, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.
Trial website
https://clinicaltrials.gov/study/NCT01677052
Trial related presentations / publications
De Potter T, Van Herendael H, Balasubramaniam R, Wright M, Agarwal SC, Sanders P, Khaykin Y, Latcu DG, Maury P, Pani A, Hayes J, Kalman J, Nery P, Duncan E. Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry. Europace. 2018 Nov 1;20(FI_3):f410-f418. doi: 10.1093/europace/eux290.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01677052