Clinical trial NCT00806689: Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: heart rhythm surveillance
follow-up
atrial fibrillation success
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are scheduled for cardiac surgery and who also present with any kind of atrial fibrillation.

Brief 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Atrial fibrillation burden development after surgical ablation therapy
timeFrame: 3 years
Secondary outcomes:
measure: Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
state: Schleswig-Holstein
Study officials:
affiliation: Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
name: Hans-H. Sievers, M.D.
role: STUDY_DIRECTOR
affiliation: Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
name: Thorsten Hanke, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
name: Ulrich Stierle, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.