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

Study Overview
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Brief Summary
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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
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Cardiac rhythm monitor implantation
* Device: Reveal® XT 9525


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac surgery patients<br>Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure | Procedure: Cardiac rhythm monitor implantation<br>* post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy<br>* Other names: Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA;Device: Reveal® XT 9525<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation burden development after surgical ablation therapy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rhythm surveillance, follow-up, atrial fibrillation success