CArdioSurgEry Atrial Fibrillation Register | NCT03091452

Studies
CArdioSurgEry Atrial Fibrillation Register

NCT03091452

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Status

Recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

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

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Mar 13, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 27, 2017Actual

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

Dec 17, 2025

Last Update Posted Date

Dec 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.

Detailed Description

CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered:

Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation?
How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out?
Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)?
Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up?
What is the concommitant medical treatment after surgical ablation?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of major bleeding events	Documentation of procedural results and clinical short-and long-term results of the documented therapies	12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of major adverse cardiac events	Documentation of procedural results and clinical short-and long-term results of the documented therapies	12 months
Complications during hospital stay	Documentation of hospital mortality, nonfatal major complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Atrial fibrilation
Treated by cardiac surgical ablation

Exclusion Criteria:

Patient denies participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients in whom atrial fibrillation is treated by cardiac surgical ablation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Belgin Özdemir	Contact	00496215032888		oezdemir@stiftung-ihf.de

Overall Officials

Name	Affiliation	Role
Thorsten Hanke, MD	Asklepios Hamburg Harburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Bogenhausen	Recruiting	München	Bavaria	81925	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38806162	Derived	Niemann B, Doll N, Grubitzsch H, Hanke T, Knaut M, Senges J, Ouarrak T, Vondran M, Boning A. Surgical Ablation of Atrial Fibrillation in High-Risk Patients: Success versus Risk. Thorac Cardiovasc Surg. 2025 Aug;73(5):373-386. doi: 10.1055/a-2334-9039. Epub 2024 May 28.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes