Zio XT® Patch for Atrial Fibrillation
(VALIANT-AF-S Trial)
Trial Summary
What is the purpose of this trial?
* 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.
Will I have to stop taking my current medications?
If you are currently using anticoagulation (blood thinners), you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
Research Team
Paul A. Heidenreich, MD MS
Principal Investigator
VA Palo Alto Health Care System, Palo Alto, CA
Eligibility Criteria
This trial is for individuals at above-average risk of developing atrial fibrillation who don't yet show symptoms. Participants will wear a heart-rate monitor patch for two weeks. Those with existing heart rhythm issues, on anticoagulants, or conditions that could interfere with the study are likely excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Systematic Screening
Participants randomized to systematic screening will receive at-home screening with a Zio XT Patch monitor for 14 days
Follow-up
Participants are monitored for safety and effectiveness after screening through remote data collection
Data Analysis
Completion of data analysis after the follow-up period
Treatment Details
Interventions
- Zio XT® Patch
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor