Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

Study Overview
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Brief Summary
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A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

Detailed Description
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The telemetric smartphone application includes a digitized medical record, a mobile ECG device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. All patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ECG device (patients will be able to send in as many ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation.

Official Title
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Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization And Quality of Life After Cryoballoon Pulmonary vEin Isolation in Patients With Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Telemetric smartphone application
* Other: Conventional follow up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Written informed consent symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation) cryoballoon pulmonary vein isolation possession of a compatible smartphone Exclusion Criteria: Age < 18 years persistent or permanent atrial fibrillation (AF) prior catheter or surgical ablation of AF pregnant females contraindication for oral anticoagulation manifest hyper-/hypothyroidism no intention to cooperate alcoholism

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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional follow up<br>Conventional follow up at physician practice | Other: Conventional follow up<br>* Conventional follow up at physician practice<br>|
| Experimental: Telemetric smartphone application<br>Structured follow up with a telemetric smartphone application | Device: Telemetric smartphone application<br>* Structured follow up with a telemetric smartphone application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization Recurrence of AF | Rate of rehospitalization after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation, Recurrence of sustained atrial fibrillation (>30 seconds) after atrial fibrillation ablation | in 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Vein Isolation, Telemetry Monitoring, Paroxysmal Atrial Fibrillation, Cryoballoon ablation