NCT06953778: VALIANT-AF-S

The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome

Not yet recruiting NA Last updated 1 May 2025

What this trial tests

NA trial testing Zio XT® Patch in Atrial Fibrillation in 24,060 participants. Not yet recruiting.

Timeline

1 June 2026

Primary endpoint
1 October 2032

3 October 2033

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	24,060
Start date	1 June 2026
Primary completion	1 October 2032
Estimated completion	3 October 2033
Sites	1 location across United States

Drugs / interventions tested

• Zio XT® Patch

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

65 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and severe bleeding reduces the risk of stroke or heart failure.
* Atrial fibrillation is a common heart condition in which one of the heart chambers doesn't follow a normal rhythm. Blood clots can form as a result, and they can travel to the brain and cause strokes, or to other organs.
* Almost everyone with atrial fibrillation is treated with drugs called anticoagulants ("blood thinners") to reduce the risk of stroke. These drugs also increase the risk of bleeding.
* Testing for atrial fibrillation is usually done for patients who have symptoms of an irregular or unusually fast or slow heartbeat, often called "palpitations" or a sensation of the heart pounding or stopping for a short period of time.
* What is not known is whether screening people who do not have symptoms of atrial fibrillation, but who are at above-average risk of getting atrial fibrillation, will reduce death, hospitalization for stroke, blood clots, heart failure more than it increases hospitalization for severe bleeding.
* People who participate in the trial who are selected by chance to receive screening will wear a small heart-rate monitor (Zio Patch) on their skin for 14 days and then return it to the manufacturer. Their doctors will be notified about the results and will make decisions about any treatment to recommend.
* The screening trial is expected to enroll about 24,000 VA patients nationwide and to last 7 years, but each person's active participation in the trial is completed after sending in the Zio Patch. After that, the study team will just collect information from the participant's electronic medical records.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.