German Ablation Quality-Register

Deutsches Ablations-Qualitätsregister

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmia

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

• Study Type: Observational
• Enrollment (Actual): 20663

Contacts and Locations

Study Locations

• Germany
  • Bad Neustadt / Saale, Germany, 97616
    • Herz- und Gefäßklinik
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Bonn, Germany, 53115
    • St. Marien Hospital
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Dresden, Germany
    • Praxisklinik Herz und Gefäß,
  • Hamburg, Germany, 20246
    • Universitares Herzzentrum Hamburg
  • Hamburg, Germany, 20099
    • Asklepios Klinik St Georg
  • Hildesheim, Germany, 31134
    • Städt Klinikum Hildesheim
  • München, Germany, 81925
    • Krankenhaus München Bogenhausen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all consecutive patients with an performed or attempted electrophysiological ablation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Missing signed informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.	01/06/2008-12/31/2011

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 medication therapy at hospital discharge	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
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 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

Collaborators and Investigators

• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Investigators: Principal Investigator: Jochen Senges, MD, Stiftung Institut fuer Herzinfarktforschung

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Catheter ablation; Cardiac arrhythmia; Register
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Ablations Register

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not included in informed consent.