Optimise post PVI management using ambulant continuous patient-driven eHealth monitoring after catheter ablation in the treatment of atrial fibrillation.Primary Objective:1) Determine the effect of eHealth on clinical management, outcomes and…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Atrial fibrillation is a major public health problem and is the most common
cardiac arrhythmia, affecting an estimated 4.5 million people in Europe. The
true prevalence of atrial fibrillation is likely underestimated because
episodes are often sporadic; therefore, it is challenging to detect and record
an occurrence in a *real world* setting. Catheter ablation, pulmonary vein
isolation (PVI), has shown to be a safe and effective treatment strategy for AF
and therefore it has become an established invasive strategy for drug
refractory AF.
After PVI, 30-60% of patients show recurrent episodes of AF. Previous studies
have demonstrated that the overall prevalence of undiagnosed AF is
underestimated, and active screening and monitoring should be pursued. Prompt
recording of a 12-lead ECG is an effective and cost-effective method to
document chronic forms of AF, but paroxysmal AF is more often missed. The
technology to detect paroxysmal, self-terminating AF episodes is rapidly
evolving. Evidence shows that prolonged ECG monitoring enhances the detection
of undiagnosed AF. The detection of asymptomatic and paroxysmal AF by new
technologies, such as smartphone cases with ECG electrodes, smart watches, and
blood pressure machines with AF detection algorithms, has not yet been formally
evaluated against an established arrhythmia detection method, but looks
promising. The use and implementation of electronic-health (eHealth) is being
encouraged by the Hearth Rhythm Society(HRS) and European Hearth Rhythm
Association (EHRA), as stated in their position statements of 2012 and 2015.
This study will evaluate a mobile eHealth device to detect recurrent atrial
arrhythmias after PVI and to evaluate the impact on patient outcomes and
quality of life.
Study objective
Optimise post PVI management using ambulant continuous patient-driven eHealth
monitoring after catheter ablation in the treatment of atrial fibrillation.
Primary Objective:
1) Determine the effect of eHealth on clinical management, outcomes and quality
of life compared to standard of care follow up
Secondary Objectives:
1) Determine the diagnostic performance and reliability
2) Determine the usability and applicability in daily practice.
Study design
Longitudinal cohort study
Study burden and risks
Patients receive additional means for cardiac rhythm monitoring to encourage
self-management and early detection. Thereby, recurrent cardiac arrhythmias
might be recognised earlier and improved quality of life might be achieved
earlier. Standard of care will not be restricted unless the treating
cardiologist deems it appropriate.
Koekoekslaan 1
Nieuwegein 3430VB
NL
Koekoekslaan 1
Nieuwegein 3430VB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL62457.100.17 |
OMON | NL-OMON22619 |