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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Rehospitalization Recurrence of AF
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional follow up
Conventional follow up at physician practice
Intervention: Conventional follow up (Other)
Telemetric smartphone application
Structured follow up with a telemetric smartphone application
Intervention: Telemetric smartphone application (Device)
Outcomes
Primary Outcomes
Rehospitalization Recurrence of AF
Time Frame: in 12 months follow up
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
Secondary Outcomes
No secondary outcomes reported