Paroxysmal Atrial FibrillationTRACE-AFNCT03268707
Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization
A study testing Telemetric smartphone application and Conventional follow up in people with Paroxysmal Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Telemetric smartphone application and Conventional follow up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Jul 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Not yet recruiting
Asklepios St Georg
Hamburg, 20246
Stephan Willems, 49 40 181885-3034, s.willems@asklepios.com
Kai Jaquet, 49 40 181885-3034, k.jaquet@asklepios.com
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Melanie Gunawardene, 40741059471, m.gunawardene@uke.de
Christian Meyer, 40741059471, chr.meyer@uke.de
About this study
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
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.
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Telemetric smartphone application, Conventional follow up
- Keywords
- Paroxysmal Atrial Fibrillation, Pulmonary Vein Isolation, Telemetry Monitoring, Cryoballoon ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemetric smartphone applicationDevice
Structured follow up with a telemetric smartphone application
Conventional follow upOther
Conventional follow up at physician practice
| Study group | Role | What they receive |
|---|---|---|
| Conventional follow up | Other | Conventional follow up at physician practice Receives: Other: Conventional follow up |
| Telemetric smartphone application | Experimental | Structured follow up with a telemetric smartphone application Receives: Device: Telemetric smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: in 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start15 Jul 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Meyer, MD, Principal investigator, Universitaeres Herzzentrum Hamburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268707
- Sponsor's protocol ID
- PV5361
- Acronym
- TRACE-AF
- Status last verified
- Jun 2019
- First submitted
- 2 Aug 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03268707
- Acronym / sponsor ID
- TRACE-AF / PV5361
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, Pulmonary Vein Isolation, Telemetry Monitoring, Cryoballoon ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional follow up | Other | Other: Conventional follow upConventional follow up at physician practice |
| Telemetric smartphone application | Experimental | Device: Telemetric smartphone applicationStructured follow up with a telemetric smartphone application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Age < 18 years
- persistent or permanent atrial fibrillation (AF)
- prior catheter or surgical ablation of AF
- pregnant females
- contraindication for oral anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemetric smartphone applicationStructured follow up with a telemetric smartphone application | Device | Telemetric smartphone application |
| Conventional follow upConventional follow up at physician practice | Other | Conventional follow up |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Meyer, MD principal investigator
Universitaeres Herzzentrum Hamburg GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemetric smartphone application and Conventional follow up in people with Paroxysmal Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Gunawardene, MD (004940741054120, m.gunawardene@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization Recurrence of AF (time frame: in 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.