ABLATOR Ablation Observational Registry

Atrial Fibrillation Clinical Trial

— ABLATOR  

Official title:

ABLATOR Ablation Observational Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344173
• Other study ID #: CRD_723
• Status: Completed
• Start date: November 2014
• Est. completion date: August 18, 2017

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Description:

The objectives of this registry are the following:

• To confirm patient safety as part of the post market surveillance study.

• To assess performance of a combination of SJM products during procedures.

• To assess the learning curve with a combination of SJM products.

• To collect operator feedback on a combination of SJM products.

All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.

In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2035
• Est. completion date: August 18, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion Criteria:

Pregnant women.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus Linz	Linz
Belgium	AZ Middelheim	Antwerpen
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	CHR Citadelle	Liège
Canada	Foothills Medical Center	Calgary
Canada	QE II Health Sciences	Hailfax
Canada	Royal Jubilee hospital	Newmarket
Canada	Institut de Cardiologie de Quebec (Hôpital Laval)	Quebec
China	Fuwai Heart Hospital & Cardiovascular Institute	Beijing
China	Third Xiangya Hospital of Central South University	Changsha
China	West China Hospital	Chengdu
China	Sir Run Run Shaw Hospital	Hangzhou
China	Prince of Wales Hospital	Hong Kong
China	Ningbo 1st. Hospital	Ningbo
Czechia	FN U sv. Anny v Brno	Brno
France	Clinique Rhône-Durance-Avignon	Avignon
France	CHU Brest	Brest
France	CHU Gabriel Montpied	Clermont-Ferrand
France	CHRU Lille	Lille
France	Clinique Pasteur	Toulouse
Germany	Zentralklinikum Bad Berka	Bad Berka
Germany	Herz- und Gefässzentrum Bad Bevensen	Bad Bevensen
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Immanuel Klinikum Bernau - Herzzentrum Brandenburg	Bernau
Germany	Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem	Göttingen
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Köln	Köln
Germany	Herzzentrum Leipzig	Leipzig
Germany	Märkische Kliniken GmbH Klinikum Lüdenscheid	Lüdenscheid
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Kliniken Maria Hilf	Mönchengladbach
India	Fortis Hospital Limited	Bangalore
India	Medanta - The Medicity Hospital	Gurgaon
India	Escorts Heart Institute and Research Centre	New Delhi
India	Christian Medical College & Hospital	Vellore
Italy	Ospedale SS Antonio e Biagio	Alessandria
Italy	Ospedale Cardinal Massaia	Asti	Piedmon
Italy	Fondazione Giovanni Paolo II	Campobasso
Italy	Ospedale San Giovanni di Dio - Torregalli	Firenze	Toscane
Italy	Ospedale Spirito Santo	Pescara
Italy	Ospedale San Filippo Neri	Roma
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Yonsei University Health System	Seoul
Netherlands	Haga Hospital	Den Haag
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Erasmus Rotterdam	Rotterdam
Portugal	Hospital Santa Cruz	Carnaxide
Portugal	Hospital Santa Maria	Lisbon
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh
Spain	Hospital general Universitario de Alicante	Alicante
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital do Meixoeiro	Vigo
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Castle Hill Hospital	Hull
United Kingdom	Leeds General Infirmary	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  China,  Czechia,  France,  Germany,  India,  Italy,  Korea, Republic of,  Netherlands,  Portugal,  Saudi Arabia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.	Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.	12 months post procedure
Primary	Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.	Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to: Death; A serious deterioration in the health of the subject; Fetal distress, fetal death or a congenital abnormality or birth defect; A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required.	12 months post procedure