Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

Paroxysmal Atrial Fibrillation Clinical Trial

— TRACE-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268707
• Other study ID #: PV5361
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Melanie Gunawardene, MD
• Phone: 004940741054120
• Email: m.gunawardene[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Telemetric smartphone application
Structured follow up with a telemetric smartphone application

Other:
• Conventional follow up
Conventional follow up at physician practice

Locations

Country	Name	City	State
Germany	Asklepios St Georg	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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