German Ablation Quality-Register | NCT01197638

Studies
German Ablation Quality-Register

NCT01197638

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Status

Completed

Last Update Posted

Jun 17, 2016Estimated

Enrollment

20,663Actual

Phase

Not provided

Conditions

Arrhythmia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jul 29, 2010

First Submission Date that Met QC Criteria

Sep 7, 2010

First Posted Date

Sep 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2016

Last Update Posted Date

Jun 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,663Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all consecutive patients with an performed or attempted electrophysiological ablation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Senges, MD	Stiftung Institut fuer Herzinfarktforschung	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz- und Gefäßklinik		Bad Neustadt / Saale		97616	Germany
Vivantes Klinikum Am Urban

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34664789	Derived	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.
32458180

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms