THERMOCOOL® SMARTTOUCH™ Registry

Symptomatic Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677052
• Other study ID #: STR-148
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: September 24, 2014
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Symptomatic Atrial Fibrillation

Locations

Country	Name	City	State
Australia	St. Andrew's Hospital	Adelaide
Australia	The Prince Charles Hospital	Adelaide
Australia	University of Adelaide/Royal Adelaide Hospital	Adelaide	South Australia
Australia	Melbourne Health/Royal Melbourne Hospital	Parkville	Victoria
Belgium	OLV Hospital Aalst Cardiovascular Center	Aalst
Belgium	CHU Brugmann	Brussels
Belgium	UZ Brussel	Brussels
Belgium	Ziekenhuis Oost-Limburg, Genk	Genk
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Hopital Laval	Quebec
France	Clinique Hopital Prive de Parly II	Le Chesnay
France	CHU Rangueil Toulouse	Toulouse Cedex
France	Clinique Infirmerie Protestante	Villeurbanne
Germany	Herz-und GefaB-Klinik, Bad Neustadt	Bad Neustadt
Germany	Charite Campus Mitte	Berlin
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Ludwig Maximilian University of Munich	Munich
Italy	Ospedale Miulli	Acquaviva delle Fonti
Italy	ASL no. 6	Cirie (TO)
Italy	Ospedale Manzoni di Lecco	Lecco
Italy	Giacomo and Cristoforo Hospital	Massa
Monaco	CH Princesse Grace	Monte Carlo
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Bristol Heart Institute	Bristol
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Glenfield Hospital, Leicester	Leicester
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Monaco,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Success	Confirmation of entrance block in the pulmonary veins (acute success)	1 year	No
Primary	Contact Force	Contact force during ablation procedures	1 year	No
Primary	Adverse Events	Procedural complications and adverse events throughout the registry	1 year	Yes