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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
  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 ] [ 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 ]

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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 29, 2010
Last Updated: June 16, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Not included in informed consent.

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

ClinicalTrials.gov processed this record on September 27, 2016