Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization (TRACE-AF)

June 15, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
        • Contact:
      • Hamburg, Germany, 20246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Conventional follow up
Conventional follow up at physician practice
Other: Conventional follow up
Conventional follow up at physician practice
Experimental: Telemetric smartphone application
Structured follow up with a telemetric smartphone application
Device: Telemetric smartphone application
Structured follow up with a telemetric smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Christian Meyer, MD, Universitaeres Herzzentrum Hamburg GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 15, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV5361

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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