Recruiting

Heart rhythm procedure with or without a clot-prevention device in older adults

Plain-English translation of NCT07441382 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial compares two ways to treat atrial fibrillation (an irregular heartbeat) in older, frail adults. One approach combines a catheter ablation procedure—which uses heat to correct the heart rhythm—with a small device that blocks the heart's appendage to prevent blood clots. The other uses the same ablation procedure but relies on blood-thinning medication instead of the device to prevent clots.

Many older adults with irregular heartbeats are at high risk for stroke because of blood clots, but they often cannot safely take blood-thinning medications due to bleeding risks. This study explores whether the clot-prevention device might be a safer alternative to long-term blood thinners in this vulnerable population.

Do you qualify?

You likely qualify if…

you are at least 75 years old
you have been diagnosed with non-valvular atrial fibrillation (paroxysmal or persistent)
you have a high stroke risk score (CHA₂DS₂-VASc of 3 or higher)
you are moderately frail (CFS score 4–6, not severely frail)
you have had or are scheduled to have a catheter ablation procedure for your heart rhythm
you are able and willing to attend all follow-up visits and complete study assessments

You likely don't qualify if…

you have had a major bleeding event in the past two weeks
you have a blood clot in your heart's left atrium or appendage
you need blood-thinning medication for reasons other than stroke prevention from atrial fibrillation
you have had a recent heart attack, stroke, or procedure (other than ablation) within the past 30–90 days
you have severe heart failure (NYHA Class IV) or a life expectancy of less than two years

What participation looks like

Participants will be randomly assigned to one of two groups. One group will receive a catheter ablation procedure combined with a left atrial appendage occlusion device (placed during the same procedure or in a follow-up visit) to prevent clots without blood thinners. The other group will receive catheter ablation followed by long-term blood-thinning medication. Both groups will have regular follow-up visits to check their heart rhythm, overall health, and any side effects or complications.

AI-generated summary from trial data · Jun 19, 2026 · Not medical advice

Trial locations(1 site)

China

Guangdong Provincial People's Hospital, Guangzhou, Guangdong

View full record on ClinicalTrials.gov