Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

  • STATUS
    Recruiting
  • End date
    Jun 30, 2021
  • participants needed
    100
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 23 January 2021
atrial fibrillation
paroxysmal atrial fibrillation
pulmonary vein isolation

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.

Details
Condition Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia, paroxysmal af
Treatment Telemetric smartphone application, Conventional follow up
Clinical Study IdentifierNCT03268707
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Paroxysmal Atrial Fibrillation?
Do you have any of these conditions: Dysrhythmia or Paroxysmal Atrial Fibrillation or Atrial Fibrillation (Pediatric) or Arrhythmia or Atrial Fibrillation or paroxysmal af?
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
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