N/A N=100 Randomized Diagnostic

A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT03557034 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Time to Atrial Fibrillation Detection — 85.0; 77.6 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Kardia Monitoring (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Atrial Fibrillation Detection	85.0; 77.6	—
SECONDARY Incidence of Atrial Fibrillation After Successful AF Ablation	7; 11	—
SECONDARY Number of Atrial Fibrillation Episodes Detected	11	—
SECONDARY Average Number of Clinical Encounters After Successful Ablation	2.9; 1.96	—
SECONDARY Number of Participants Using Alternative Monitoring Devices After Successful Ablation	13; 3	—
SECONDARY Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period	-1.23; 0.0	—

Summary

Pulmonary vein isolation is a widely used strategy for the treatment of patients with symptomatic atrial fibrillation. After successful pulmonary vein isolation (no atrial fibrillation on transtelephonic rhythm recordings for 3 months following ablation), heart rhythm is not routinely monitored. The goal of this study is to determine whether the Kardia Mobile device detects AF at a different rate compared to our standard of care. The study also hopes to understand how this Kardia Mobile device and Kardia Pro platform affect health care utilization and patient anxiety.

Eligibility Criteria

Inclusion Criteria

18-85 years old
Have smartphone with data plan
History of AF (paroxysmal or persistent)
In sinus rhythm at the 3-4 month post-procedure visit and no evidence of AF during the interval starting after the 3 week blanking period and ending at the appointment time.
On Anticoagulation if CHADS VASC score is ≥ 1 and will continue to be on anticoagulation or CHADS VASC of Zero
Willing to follow up with their Cleveland Clinic electrophysiologist in 6 months

Exclusion Criteria

Patients without smartphone
Unwilling to provide consent
Unwilling to follow up in 6 months
CHADS VASC ≥ 1 and anticoagulation will be stopped
Presence of a cardiac implantable electronic device
If the primary electrophysiologist decides the patient still needs monitoring through traditional monitors due to any reason

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03557034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.