ABLATOR Ablation Observational Registry

NCT02344173 | Completed Results

• 1 other identifier: CRD_723
• Study Type: observational
• Target: 2,035
• Locations: 15 countries
• Sites: 62

Brief 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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pregnant women.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (62)

Allgemeines Krankenhaus Linz

Linz, Austria

Location

AZ Middelheim

Antwerp, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

CHR Citadelle

Liège, Belgium

Location

Foothills Medical Center

Calgary, Canada

Location

QE II Health Sciences

Hailfax, Canada

Location

Royal Jubilee hospital

Newmarket, Canada

Location

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, Canada

Location

Fuwai Heart Hospital & Cardiovascular Institute

Beijing, China

Location

Third Xiangya Hospital of Central South University

Changsha, China

Location

West China Hospital

Chengdu, China

Location

Sir Run Run Shaw Hospital

Hangzhou, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

Ningbo 1st. Hospital

Ningbo, China

Location

FN U sv. Anny v Brno

Brno, Czechia

Location

Clinique Rhône-Durance-Avignon

Avignon, France

Location

CHU Brest

Brest, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, France

Location

CHRU Lille

Lille, France

Location

Clinique Pasteur

Toulouse, France

Location

Zentralklinikum Bad Berka

Bad Berka, Germany

Location

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, Germany

Location

Kerckhoff Klinik

Bad Nauheim, Germany

Location

Vivantes Klinikum Am Urban

Berlin, Germany

Location

Immanuel Klinikum Bernau - Herzzentrum Brandenburg

Bernau, Germany

Location

Universitätsklinikum Köln

Cologne, Germany

Location

Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem

Göttingen, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

Märkische Kliniken GmbH Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

Kliniken Maria Hilf

Mönchengladbach, Germany

Location

Fortis Hospital Limited

Bangalore, India

Location

Medanta - The Medicity Hospital

Gūrgaon, India

Location

Escorts Heart Institute and Research Centre

New Delhi, India

Location

Christian Medical College & Hospital

Vellore, India

Location

Ospedale Cardinal Massaia

Asti, Piedmon, 14100, Italy

Location

Ospedale San Giovanni di Dio - Torregalli

Florence, Tuscany, 50122, Italy

Location

Ospedale SS Antonio e Biagio

Alessandria, Italy

Location

Fondazione Giovanni Paolo II

Campobasso, Italy

Location

Ospedale Spirito Santo

Pescara, Italy

Location

Ospedale San Filippo Neri

Roma, Italy

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Erasmus Rotterdam

Rotterdam, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

Hospital Santa Cruz

Carnaxide, Portugal

Location

Hospital Santa Maria

Lisbon, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, Portugal

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Yonsei University Health System

Seoul, South Korea

Location

Hospital general Universitario de Alicante

Alicante, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Hospital do Meixoeiro

Vigo, Spain

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Castle Hill Hospital

Hull, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

SAEs were adjudicated by the sponsor.

Results Point of Contact

• Title: Principal Clinical Research Scientist
• Organization: Abbott

eric.grovender@abbott.com

6517564067

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 22, 2015
• Study Start: November 1, 2014
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2019-02

Locations

DE (12); IN (4); KR (4); FR (5); IT (6); GB (4); BE (3); AU (1); CZ (1); PT (3); ES (5); CA (4); CN (6); SA (1); NL (3)