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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.

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. - iSCAN

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44247
Enrollment
100
Registered
2018-03-01
Start date
2018-07-20
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrialfibrillation

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Patients monitored with continuous heart rhythm monitor (e.g. PM, ICD, ILR) * Participation in a conflicting study

Design outcomes

Primary

MeasureTime frame
Effect on post-PVI management: - Arrhythmia detection (AF, Aflut, AT, SVT) - Time until arrhythmia detection - Medication management (AAD, OAC) - Time until discontinuation AAD and OAC - Healthcare Consumption

Secondary

MeasureTime frame
- diagnostic accuracy studie 1) sensitivity 2) specificity 3) positive and negative predicting values 4) Cohens kappa Kardia - Holter, Kardia application - Cardiologist - Usefulness and applicability eHealth 1) ease of use 2) availability when demanded 3) technical quality 4) compliance 5) User satisfaction (patient and physician) 6) Quality of Life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)