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Clinical Trials/NCT03268707
NCT03268707UnknownNot Applicable

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

Universitätsklinikum Hamburg-Eppendorf4 sites in 1 country100 target enrollmentStarted: July 15, 2017Last updated:
Conditions
Interventions

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

Other

Conventional follow up at physician practice

Intervention: Conventional follow up (Other)

Telemetric smartphone application

Experimental

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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