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

July 29, 2010
September 7, 2010
June 2008
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01197638 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
German Ablation Quality-Register
Deutsches Ablations-Qualitätsregister

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

all consecutive patients with an performed or attempted electrophysiological ablation

Arrhythmia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
Not Provided
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing signed informed consent
Both
Not Provided
No
Not Provided
Germany
 
NCT01197638
Ablations Register
No
Prof Jochen Senges, Institut für Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
Not Provided
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP