German Ablation Quality-Register

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197638
First received: July 29, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

The goal of this register is the documentation of the success as well as of the complications regarding interventional therapy of cardiac arrhythmia by catheter ablation. This is the necessary basis for quality management and development of possible improvements of catheter ablation.


Condition
Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Deutsches Ablations-Qualitätsregister

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany. [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documentation of the technical implementation of ablation and the success of the intervention [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of further necessary interventions after the initial ablation during hospital stay [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of hospital mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), and complications caused by bleedings (serious as well as moderate) [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of medication therapy at hospital discharge [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of the 1-year mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), of heavy bleedings, of phrenicus pareses, PV-stenoses, or fistulas [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of the absence of relapse and of symptomatology after one year [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of needed interventions (implantation of either pacemaker, ICD or CRT, revascularization, a further ablation) during the first year after ablation [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of hospitalizations during the first year after ablation [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of medication therapy after 12 months [ Time Frame: 01/06/2008-12/31/2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: June 2008
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all consecutive patients with an performed or attempted electrophysiological ablation

Criteria

Inclusion Criteria:

  • The ablation register will include all consecutive patients with a performed or attempted electrophysiological ablation

Exclusion Criteria:

  • Missing signed informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197638

Locations
Germany
Herz- und Gefäßklinik Recruiting
Bad Neustadt / Saale, Germany, 97616
Contact: Burghard Schumacher, MD       schumacher@kardiologie-bad-neustadt.de   
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany, 10967
Contact: Dietrich Andresen, MD       Dietrich.Andresen@vivantes.de   
St. Marien Hospital Recruiting
Bonn, Germany, 53115
Contact: Th Lewalter, MD       th.lewalter@uni-bonn.de   
Klinikum Coburg Recruiting
Coburg, Germany, 96450
Contact: Johannes Brachmann, MD       johannes.brachmann@klinikum-coburg.de   
Praxisklinik Herz und Gefäß, Recruiting
Dresden, Germany
Contact: Stefan G Spitzer, MD       dr.spitzer@praxisklinik-dresden.de   
Asklepios Klinik St Georg Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, MD       k.kuck@asklepios.com   
Universitäres Herzzentrum Hamburg Recruiting
Hamburg, Germany, 20246
Contact: S Willems, MD       willems@uke.uni-hamburg.de   
Städt Klinikum Hildesheim Recruiting
Hildesheim, Germany, 31134
Contact: Jürgen Tebbenjohanns, MD       j.tebbenjohanns@stk-hildesheim.de   
Krankenhaus München Bogenhausen Recruiting
München, Germany, 81925
Contact: Ellen Hoffmann, MD       ellen.hoffmann@klinikum-muenchen.de   
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
  More Information

No publications provided

Responsible Party: Prof Jochen Senges, Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01197638     History of Changes
Other Study ID Numbers: Ablations Register
Study First Received: July 29, 2010
Last Updated: September 7, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Cardiac arrhythmia
Catheter ablation
Register

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014