NCT01197638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,663

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

July 29, 2010

Last Update Submit

June 16, 2016

Conditions

Arrhythmia

Keywords

Cardiac arrhythmiaCatheter ablationRegister

Outcome Measures

Primary Outcomes (1)

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

    01/06/2008-12/31/2011

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all consecutive patients with an performed or attempted electrophysiological ablation

You may qualify if:

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

You may not qualify if:

  • Missing signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Herz- und Gefäßklinik

Bad Neustadt / Saale, 97616, Germany

Location

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

St. Marien Hospital

Bonn, 53115, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Praxisklinik Herz und Gefäß,

Dresden, Germany

Location

Asklepios Klinik St Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Städt Klinikum Hildesheim

Hildesheim, 31134, Germany

Location

Krankenhaus München Bogenhausen

München, 81925, Germany

Location

Related Publications (2)

  • 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.

    PMID: 34664789DERIVED

  • 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.

    PMID: 32458180DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jochen Senges, MD

    Stiftung Institut fuer Herzinfarktforschung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

September 9, 2010

Study Start

June 1, 2008

Primary Completion

August 1, 2011

Study Completion

February 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Not included in informed consent.

Locations

DE(9)