Implementing Self management using eHealth for monitoring and management after Catheter ablation in the treatment of Atrial fibrillatioN. A study on the diagnostic accuracy and the effects of eHealth rhythm monitoring on patient related outcomes, clinical management and health outcomes.
Completed
- Conditions
- atrialfibrillation10007521
- Registration Number
- NL-OMON44247
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
* Patients 18 years and over
* a history of documented palpitation driven paroxysmal atrial fibrillation or symptomatic persistent atrial fibrillation.
* Scheduled for index PVI procedure
* Already utilises a smartphone or tablet compatible with required software prior to enrolment
Exclusion Criteria
* Patients monitored with continuous heart rhythm monitor (e.g. PM, ICD, ILR)
* Participation in a conflicting study
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Effect on post-PVI management:<br /><br>- Arrhythmia detection (AF, Aflut, AT, SVT)<br /><br>- Time until arrhythmia detection<br /><br>- Medication management (AAD, OAC)<br /><br>- Time until discontinuation AAD and OAC<br /><br>- Healthcare Consumption</p><br>
- Secondary Outcome Measures
Name Time Method <p>- diagnostic accuracy studie<br /><br>1) sensitivity<br /><br>2) specificity<br /><br>3) positive and negative predicting values<br /><br>4) Cohens kappa Kardia - Holter, Kardia application - Cardiologist<br /><br><br /><br>- Usefulness and applicability eHealth<br /><br>1) ease of use<br /><br>2) availability when demanded<br /><br>3) technical quality<br /><br>4) compliance<br /><br><br /><br>5) User satisfaction (patient and physician)<br /><br>6) Quality of Life</p><br>