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Completed

NCT Number: NCT01197638

German Ablation Quality-Register

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Gefäßklinik, Bad Neustadt / Saale, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Missing signed informed consent

Treatment and study plan

Primary outcomes

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

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

Secondary outcomes

  1. Documentation of the technical implementation of ablation and the success of the intervention

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

  2. Documentation of further necessary interventions after the initial ablation during hospital stay

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

  3. 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

  4. Documentation of medication therapy at hospital discharge

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

  5. 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

  6. Documentation of the absence of relapse and of symptomatology after one year

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

  7. 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

  8. Documentation of hospitalizations during the first year after ablation

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

  9. Documentation of medication therapy after 12 months

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

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Registry information

Official study title

Deutsches Ablations-Qualitätsregister

Important dates

Study start
2008
Primary completion
2011
Study completion
2016
First posted
Sep 9, 2010
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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