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German Ablation Quality-Register

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197638
First received: July 29, 2010
Last updated: June 16, 2016
Last verified: June 2016

July 29, 2010
June 16, 2016
June 2008
August 2011   (final data collection date for primary outcome measure)
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.

The interventional therapy of heartbeat disturbances by means of catheter ablation makes the curative treatment possible of numerous tachycardiac arrhythmics. By this crucial improvement of the supply of patients and its quality of life a genuine healing of a multiplicity of heartbeat disturbances became possible. Especially within the range of the ablation treatment there are relatively few con-trolled studies, which would give a broad collection of the results of the catheter ablation in the different indication areas.

Aim of the registry:

Documentation of indication, hospital course and complications during long term follow-up of patients with catheter ablation

Design:

Prospective, multicenter registry; FU-duration 12 months.

Duration:

Phase I: 2 years

Inclusion criteria:

Catheter ablation (intention to treat)

Exclusion criteria:

Missing declaration of consent

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.
 
Completed
20663
February 2016
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing signed informed consent
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01197638
Ablations Register
No
No
Not included in informed consent.
Stiftung Institut fuer Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
Not Provided
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
June 2016

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