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German Ablation Quality-Register

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197638
First Posted: September 9, 2010
Last Update Posted: June 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
  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

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 ]

Secondary Outcome Measures:
  • Documentation of the technical implementation of ablation and the success of the intervention [ Time Frame: 01/06/2008-12/31/2011 ]
  • Documentation of further necessary interventions after the initial ablation during hospital stay [ Time Frame: 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) [ Time Frame: 01/06/2008-12/31/2011 ]
  • Documentation of medication therapy at hospital discharge [ Time Frame: 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 [ Time Frame: 01/06/2008-12/31/2011 ]
  • Documentation of the absence of relapse and of symptomatology after one year [ Time Frame: 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 [ Time Frame: 01/06/2008-12/31/2011 ]
  • Documentation of hospitalizations during the first year after ablation [ Time Frame: 01/06/2008-12/31/2011 ]
  • Documentation of medication therapy after 12 months [ Time Frame: 01/06/2008-12/31/2011 ]

Enrollment: 20663
Study Start Date: June 2008
Study Completion Date: February 2016
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197638


Locations
Germany
Herz- und Gefäßklinik
Bad Neustadt / Saale, Germany, 97616
Vivantes Klinikum Am Urban
Berlin, Germany, 10967
St. Marien Hospital
Bonn, Germany, 53115
Klinikum Coburg
Coburg, Germany, 96450
Praxisklinik Herz und Gefäß,
Dresden, Germany
Asklepios Klinik St Georg
Hamburg, Germany, 20099
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 20246
Städt Klinikum Hildesheim
Hildesheim, Germany, 31134
Krankenhaus München Bogenhausen
München, Germany, 81925
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
  More Information

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01197638     History of Changes
Other Study ID Numbers: Ablations Register
First Submitted: July 29, 2010
First Posted: September 9, 2010
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not included in informed consent.

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