Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Telemetric smartphone application; Other: Conventional follow up

• Registration Number: NCT03268707
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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 Timeline

• Study Start: 2017-07-15
• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-15
• Last Update Posted: 2019-06-18
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Telemetric smartphone application	Telemetric smartphone application	Structured follow up with a telemetric smartphone application
Conventional follow up	Conventional follow up	Conventional follow up at physician practice

Primary Outcome Measures

Name	Time	Method
Rehospitalization Recurrence of AF	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

Trial Locations

Locations (2)

Asklepios St Georg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany