Clinical trial NCT01197638: German Ablation Quality-Register
Official title: Deutsches Ablations-Qualitätsregister
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Keywords: Cardiac arrhythmia
Catheter ablation
Register
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 20663
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients with an performed or attempted electrophysiological ablation

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

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

Primary outcomes:
measure: Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.
timeFrame: 01/06/2008-12/31/2011
Secondary outcomes:
measure: Documentation of the technical implementation of ablation and the success of the intervention
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of further necessary interventions after the initial ablation during hospital stay
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of hospital mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), and complications caused by bleedings (serious as well as moderate)
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of medication therapy at hospital discharge
timeFrame: 01/06/2008-12/31/2011
measure: 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
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of the absence of relapse and of symptomatology after one year
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of needed interventions (implantation of either pacemaker, ICD or CRT, revascularization, a further ablation) during the first year after ablation
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of hospitalizations during the first year after ablation
timeFrame: 01/06/2008-12/31/2011
measure: Documentation of medication therapy after 12 months
timeFrame: 01/06/2008-12/31/2011
Other outcomes:
Locations:
city: Bad Neustadt / Saale
country: Germany
facility: Herz- und Gefäßklinik
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Bonn
country: Germany
facility: St. Marien Hospital
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefäß,
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Hildesheim
country: Germany
facility: Städt Klinikum Hildesheim
city: München
country: Germany
facility: Krankenhaus München Bogenhausen
Study officials:
affiliation: Stiftung Institut fuer Herzinfarktforschung
name: Jochen Senges, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schleberger R, Metzner A, Kuck KH, Andresen D, Willems S, Hoffmann E, Deneke T, Eckardt L, Brachmann J, Hochadel M, Senges J, Rillig A. Antiarrhythmic drug therapy after catheter ablation for atrial fibrillation-Insights from the German Ablation Registry. Pharmacol Res Perspect. 2021 Dec;9(6):e00880. doi: 10.1002/prp2.880.
citation: Dechering DG, Gonska BD, Brachmann J, Lewalter T, Kuck KH, Andresen D, Willems S, Spitzer SG, Straube F, Schumacher B, Hochadel M, Senges J, Eckardt L. Efficacy and complications of cavo-tricuspid isthmus-dependent atrial flutter ablation in patients with and without structural heart disease: results from the German Ablation Registry. J Interv Card Electrophysiol. 2021 Jun;61(1):55-62. doi: 10.1007/s10840-020-00769-z. Epub 2020 May 27.