Mobile Health Technology-Enabled AFib Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.
Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or older at time of consent
Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
BMI (Body Mass Index) ≥ 27.0
Disqualifiers
Permanent Afib (decision has been made not to attempt sinus rhythm)
Severe valvular disease
Moderate mitral valve stenosis
Prior cardiac surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Corrie Virtual Atrial Fibrillation Management Program
Combination productIntervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Treatment groups
248 Participants
are divided into 2 treatment groupsGroup A: Corrie Virtual Atrial Fibrillation Management ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Participants Freedom from documented atrial tachyarrhythmia
Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs.
Time frame
91 to 365 daysSecondary outcomes
1
Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)
Quality of Life, measured by validated Atrial Fibrillation Effect on Quality of Life (AFEQT) score. Score ranges from 0 to 100 with higher scores signifying better quality of life
Time frame
365 days2
AFib burden (percentage of time)
Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation
Time frame
91 to 365 days3
Participants Freedom from atrial tachyarrhythmia off medication
Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications.
Time frame
91 to 365 days4
Participants Freedom from atrial tachyarrhythmia on or off medications
Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications.
Time frame
1 day to 365 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Pharmaceutical Research & Manufacturers Of America Foundation
Collaborator
Apple Inc.
Collaborator
Itamar-Medical, Israel
Collaborator
Source ClinicalTrials.gov