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Left atrial appendage occlusion for patients with valvular diseases and without atrial fibrillation: a randomized controlled trial

Left atrial appendage occlusion for patients with valvular diseases and without atrial fibrillation: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042238
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-04-20
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular disease

Interventions

intervention group:left atrial appendage excision

Sponsors

Fuwai Hospital, Chinese Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 18 years of age; 2. At least undergoing mitral valve or aortic valve surgeries; 3. Without baseline atrial fibrillation and atrial flutter; 4. With CHA2DS2-VASc score >= 2; 5. Agreed to participate in the clinical study and consented to annual postoperative ultrasound examinations and telephone follow-ups.

Exclusion criteria

Exclusion criteria: 1. Undergoing heart transplantation, or complex congenital heart surgery, or ventricular assist device implantation; 2. Redo cardiovascular surgeries; 3. Left atrium diameter over 6 cm; 4. Presence of thrombus in the left atrium or LAA; 5. With a history of stroke/cerebrovascular accident within one month before surgeries.

Design outcomes

Primary

MeasureTime frame
A composition of newly occurred ischemic stroke /transient ischemic attack, and cardiovascular mortality during the 1-year, 3-year, 5-year follow up;

Secondary

MeasureTime frame
Postoperative AF (defined as newly diagnosed AF within 30 postoperative days), cardiovascular mortality, newly occurred ischemic stroke, newly occurred transient ischemic attack, newly occurred hemorrhagic stroke, bleeding events during the 1-year, 3-year, 5-year follow up.;

Countries

China

Contacts

Public ContactHansong Sun

Fuwai Hospital, Chinese Academy of Medical Science

drsunhs@sina.com+86 10 8832 2351

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026