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Clinical Trials/NCT01197638
NCT01197638
Completed
Not Applicable

Deutsches Ablations-Qualitätsregister

Stiftung Institut fuer Herzinfarktforschung9 sites in 1 country20,663 target enrollmentJune 2008
ConditionsArrhythmia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmia
Sponsor
Stiftung Institut fuer Herzinfarktforschung
Enrollment
20663
Locations
9
Primary Endpoint
Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
February 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Stiftung Institut fuer Herzinfarktforschung
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Missing signed informed consent

Outcomes

Primary Outcomes

Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.

Time Frame: 01/06/2008-12/31/2011

Secondary Outcomes

  • Documentation of hospitalizations during the first year after ablation(01/06/2008-12/31/2011)
  • Documentation of medication therapy after 12 months(01/06/2008-12/31/2011)
  • Documentation of medication therapy at hospital discharge(01/06/2008-12/31/2011)
  • Documentation of needed interventions (implantation of either pacemaker, ICD or CRT, revascularization, a further ablation) during the first year after ablation(01/06/2008-12/31/2011)
  • Documentation of hospital mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), and complications caused by bleedings (serious as well as moderate)(01/06/2008-12/31/2011)
  • Documentation of the technical implementation of ablation and the success of the intervention(01/06/2008-12/31/2011)
  • Documentation of further necessary interventions after the initial ablation during hospital stay(01/06/2008-12/31/2011)
  • 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(01/06/2008-12/31/2011)
  • Documentation of the absence of relapse and of symptomatology after one year(01/06/2008-12/31/2011)

Study Sites (9)

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