Atrial Fibrillation
Conditions
Keywords
heart rhythm surveillance, follow-up, atrial fibrillation success
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.
Interventions
PROCEDURECardiac rhythm monitor implantation
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
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.
Sponsors
University of Luebeck
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation burden development after surgical ablation therapy | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy | 3 years |
Countries
Germany
Contacts
Primary ContactThorsten Hanke, MD
Outcome results
None listed