NCT05784766

Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Patients with cancer have a higher incidence of AF but despite the higher incidence of AF in the cancer population, there are no randomized controlled trials (RCTs) for AF screening in this population. RCTs of AF screening in the general population have shown that screening can effectively detect AF earlier, and helps to identify candidates for appropriate anticoagulation that may lead to improvement in clinical outcomes.

Detailed description

The Investigators will conduct an open label, prospective, pilot RCT. After informed consent, patients will be randomized 1:1 into screening or usual care. Screening will be done at a single time point. Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). Patients randomized to usual care will not receive a screening ECG. Primary outcome will be detection of newly diagnosed AF by screening vs usual care.

Conditions

• Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	30-second ECG using the Kardia Mobile	30-second ECG using the Kardia Mobile
OTHER	routine care	medical review

Timeline

• Start date: 2023-11-06
• Primary completion: 2025-06-13
• Completion: 2027-01-01
• First posted: 2023-03-27
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study