Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization (TRACE-AF)

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Other: Conventional follow up; Device: Telemetric smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT03268707

PV5361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Conventional follow up

Other group

Description:

Conventional follow up at physician practice

Treatment:

Other: Conventional follow up

Telemetric smartphone application

Experimental group

Description:

Structured follow up with a telemetric smartphone application

Treatment:

Device: Telemetric smartphone application