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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional follow up | Other | Conventional follow up at physician practice |
|
| Telemetric smartphone application | Experimental | Structured follow up with a telemetric smartphone application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemetric smartphone application | Device | Structured follow up with a telemetric smartphone application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | in 12 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie Gunawardene, MD | Contact | 004940741054120 | m.gunawardene@uke.de | |
| Christian Meyer, MD | Contact | 004940741054120 | chr.meyer@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Meyer, MD | Universitaeres Herzzentrum Hamburg GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios St Georg | Not yet recruiting | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Conventional follow up | Other | Conventional follow up at physician practice |
|
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |