CClinicalTrials.gg
Status unknownNCT00806689Updated Jul 2, 2010

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

An observational study in Atrial Fibrillation, sponsored by University of Luebeck. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-02.

Sponsored by University of Luebeck · Observational

The sponsor has not verified this record recently (last verified Dec 2008), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
100
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • heart rhythm surveillance
  • follow-up
  • atrial fibrillation success
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Enrollment
100 participants (estimated)

Groups and cohorts

  • Cardiac surgery patients

    Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure

    Procedure: Cardiac rhythm monitor implantation · Device: Reveal® XT 9525

Interventions

  • ProcedureCardiac rhythm monitor implantation

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

    Also known as: Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA

  • DeviceReveal® 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.

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What researchers measure

Primary outcomes

  1. Atrial fibrillation burden development after surgical ablation therapy

    Time frame: 3 years

Secondary outcomes

  1. Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
    Luebeck, Schleswig-Holstein 23538, Germany
    Recruiting
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References and documents

Publications

  • Hanke T, Charitos EI, Stierle U, Karluss A, Kraatz E, Graf B, Hagemann A, Misfeld M, Sievers HH. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation. 2009 Sep 15;120(11 Suppl):S177-84. doi: 10.1161/CIRCULATIONAHA.108.838474. PubMed 19752365 ↗
  • Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. Atrial fibrillation burden estimates derived from intermittent rhythm monitoring are unreliable estimates of the true atrial fibrillation burden. Pacing Clin Electrophysiol. 2014 Sep;37(9):1210-8. doi: 10.1111/pace.12389. Epub 2014 Mar 25. PubMed 24665972 ↗
  • Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. How often should we monitor for reliable detection of atrial fibrillation recurrence? Efficiency considerations and implications for study design. PLoS One. 2014 Feb 12;9(2):e89022. doi: 10.1371/journal.pone.0089022. eCollection 2014. PubMed 24563690 ↗
  • Charitos EI, Stierle U, Ziegler PD, Baldewig M, Robinson DR, Sievers HH, Hanke T. A comprehensive evaluation of rhythm monitoring strategies for the detection of atrial fibrillation recurrence: insights from 647 continuously monitored patients and implications for monitoring after therapeutic interventions. Circulation. 2012 Aug 14;126(7):806-14. doi: 10.1161/CIRCULATIONAHA.112.098079. Epub 2012 Jul 23. Erratum In: Circulation. 2012 Sep 25;126(13):e216. PubMed 22824434 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00806689
Lead sponsor
University of Luebeck
First posted
Dec 11, 2008
Start date
Jul 2007
Primary completion
Dec 2008 (estimated)
Completion
Jul 2011 (estimated)
Last update
Jul 2, 2010

Study contacts

Thorsten Hanke, MD
Contact
Thorsten.Hanke@uk-sh.de
0049-451-500 ext. 2108
Hans-H. Sievers, M.D.
study director · Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Thorsten Hanke, M.D.
principal investigator · Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Ulrich Stierle, M.D.
study chair · Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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