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

NCT00806689 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2010-07-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Cardiac rhythm monitor implantation

post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy

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.

Sponsors & Collaborators

  • University of Luebeck

    lead OTHER

Principal Investigators

  • Hans-H. Sievers, M.D. · Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany

  • Thorsten Hanke, M.D. · Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany

  • Ulrich Stierle, M.D. · Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2011-07-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806689 on ClinicalTrials.gov