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

NCT00806689 | Unknown

• 1 other identifier: 08-046
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

heart rhythm surveillance; follow-up; atrial fibrillation success

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation burden development after surgical ablation therapy

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (1)

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

Cardiac rhythm monitor implantation PROCEDURE

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

Cardiac surgery patients

Reveal® XT 9525 DEVICE

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.

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 19752365 RESULT

• 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.

  PMID: 24665972 DERIVED

• 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.

  PMID: 24563690 DERIVED

• 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.

  PMID: 22824434 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans-H. Sievers, M.D.

  Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany

  STUDY DIRECTOR

• Thorsten Hanke, M.D.

  Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany

  PRINCIPAL INVESTIGATOR

• Ulrich Stierle, M.D.

  Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany

  STUDY CHAIR

Central Study Contacts

Thorsten Hanke, MD

CONTACT

0049-451-500; Thorsten.Hanke@uk-sh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2011
• Last Updated: July 2, 2010

Record last verified: 2008-12

Locations

DE (1)