Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conventional follow up

Conventional follow up at physician practice

Group Type OTHER

Conventional follow up

Intervention Type OTHER

Conventional follow up at physician practice

Telemetric smartphone application

Structured follow up with a telemetric smartphone application

Group Type EXPERIMENTAL

Telemetric smartphone application

Intervention Type DEVICE

Structured follow up with a telemetric smartphone application

Interventions

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Telemetric smartphone application

Structured follow up with a telemetric smartphone application

Intervention Type DEVICE

Conventional follow up

Conventional follow up at physician practice

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No