Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy

July 1, 2010 updated by: University of Luebeck

24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA) with full observational continuous heart rhythm documentation is implanted.

In order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed intraindividually. Thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who are scheduled for cardiac surgery and who also present with any kind of atrial fibrillation.

Description

Inclusion Criteria:

  • patients in atrial fibrillation (AF duration >4 months)being scheduled for cardiac surgery
  • patients with lone atrial fibrillation being scheduled for surgical AF treatment

Exclusion Criteria:

  • failure to provide informed consent
  • current participation in another clinical trial
  • organic cause of atrial fibrillation (hyperthyroidism etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac surgery patients
Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure
Procedure: Cardiac rhythm monitor implantation
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
Other Names:
  • Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA
Device: Reveal® XT 9525
During cardiac surgery after stand alone or concomitant ablation procedure, an insertable loop recorder will be implanted subcutaneously in left pectoral region. After surgery, patients will be monitored regularly in a quarterly basis by performing telemetry of the device in the outpatient clinic. Furthermore, home telemetry will be performed once a month for optimal heart rhythm observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial fibrillation burden development after surgical ablation therapy
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Investigators

  • Study Director: Hans-H. Sievers, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
  • Principal Investigator: Thorsten Hanke, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
  • Study Chair: Ulrich Stierle, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2010

Last Update Submitted That Met QC Criteria

July 1, 2010

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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