Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization (TRACE-AF)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemetric smartphone application
Conventional follow up
Sponsored by
About this trial
This is an interventional other trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, Pulmonary Vein Isolation, Telemetry Monitoring, Cryoballoon ablation
Eligibility Criteria
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
Sites / Locations
- Asklepios St Georg
- Universitätsklinikum Hamburg-EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Conventional follow up
Telemetric smartphone application
Arm Description
Conventional follow up at physician practice
Structured follow up with a telemetric smartphone application
Outcomes
Primary Outcome Measures
Rehospitalization Recurrence of AF
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 Outcome Measures
Full Information
NCT ID
NCT03268707
First Posted
August 2, 2017
Last Updated
June 15, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT03268707
Brief Title
Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization
Acronym
TRACE-AF
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, Pulmonary Vein Isolation, Telemetry Monitoring, Cryoballoon ablation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional follow up
Arm Type
Other
Arm Description
Conventional follow up at physician practice
Arm Title
Telemetric smartphone application
Arm Type
Experimental
Arm Description
Structured follow up with a telemetric smartphone application
Intervention Type
Device
Intervention Name(s)
Telemetric smartphone application
Intervention Description
Structured follow up with a telemetric smartphone application
Intervention Type
Other
Intervention Name(s)
Conventional follow up
Intervention Description
Conventional follow up at physician practice
Primary Outcome Measure Information:
Title
Rehospitalization Recurrence of AF
Description
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
Time Frame
in 12 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Gunawardene, MD
Phone
004940741054120
Email
m.gunawardene@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Meyer, MD
Phone
004940741054120
Email
chr.meyer@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
Organizational Affiliation
Universitaeres Herzzentrum Hamburg GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios St Georg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Willems
Phone
49 40 181885-3034
Email
s.willems@asklepios.com
First Name & Middle Initial & Last Name & Degree
Kai Jaquet
Phone
49 40 181885-3034
Email
k.jaquet@asklepios.com
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Gunawardene
Phone
40741059471
Email
m.gunawardene@uke.de
First Name & Middle Initial & Last Name & Degree
Christian Meyer
Phone
40741059471
Email
chr.meyer@uke.de
12. IPD Sharing Statement
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Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization
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