ClinicalTrials.gov
ClinicalTrials.gov Menu

CArdioSurgEry Atrial Fibrillation Register (CASE-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03091452
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung

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

Condition or disease
Atrial Fibrillation

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?

Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CArdioSurgEry Atrial Fibrillation Register - CASE-AF Register
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of major bleeding events [ Time Frame: 12 months ]
    Documentation of procedural results and clinical short-and long-term results of the documented therapies


Secondary Outcome Measures :
  1. Number of major adverse cardiac events [ Time Frame: 12 months ]
    Documentation of procedural results and clinical short-and long-term results of the documented therapies

  2. Complications during hospital stay [ Time Frame: 12 months ]
    Documentation of hospital mortality, nonfatal major complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in whom atrial fibrillation is treated by cardiac surgical ablation
Criteria

Inclusion Criteria:

  • Atrial fibrilation
  • Treated by cardiac surgical ablation

Exclusion Criteria:

  • Patient denies participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091452


Contacts
Contact: Alexandra Piotrowski 006215032869 piotrowski@stiftung-ihf.de

Locations
Germany
Klinikum Bogenhausen Recruiting
Munchen, Bayern, Germany, 81925
Contact: Edgar Eszlari, MD         
Schüchtermann Kliniken Recruiting
Bad Rothenfelde, NRW, Germany, 49214
Contact: Jürgen Ackemann, MD         
Asklepios Harburg Not yet recruiting
Hamburg, Germany, 21075
Contact: Thorsten Hanke, MD         
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Thorsten Hanke, MD Asklepios Hamburg Harburg

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT03091452     History of Changes
Other Study ID Numbers: CASE-AF
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes