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
Recruitment status was Recruiting
Sponsor:
Stiftung Institut fuer Herzinfarktforschung
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
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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 May 16, 2013