Suspended

TRACE-AFInfluence 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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What is being tested

Telemetric smartphone application

+ Conventional follow up

DeviceOther
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: July 2017
See protocol details

Summary

Principal SponsorUniversitätsklinikum Hamburg-Eppendorf
Study ContactMelanie Gunawardene, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleInfluence of an Innovative Telemetric Smartphone Application on Re-hospitalization And Quality of Life After Cryoballoon Pulmonary vEin Isolation in Patients With Paroxysmal Atrial Fibrillation
NCT03268707
Principal SponsorUniversitätsklinikum Hamburg-Eppendorf
Study ContactMelanie Gunawardene, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

5 inclusion criteria required to participate
Age > 18 years
Written informed consent
symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation)
cryoballoon pulmonary vein isolation
Show More Criteria
8 exclusion criteria prevent from participating
Age < 18 years
persistent or permanent atrial fibrillation (AF)
prior catheter or surgical ablation of AF
pregnant females
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Structured follow up with a telemetric smartphone application

Group II

Conventional follow up at physician practice

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Universitätsklinikum Hamburg-Eppendorf

Hamburg, GermanyOpen Universitätsklinikum Hamburg-Eppendorf in Google Maps
Recruiting soon

Asklepios St Georg

Hamburg, Germany
Suspended2 Study Centers