Active — Not RecruitingNot Applicable

Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke

China210 participantsStarted 2021-03-03

Plain-language summary

To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term anti-coagulation. And to support registration approval from National Medical Products Administration (NMPA).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. With a recorded history (happened earlier than 6 months from now) of bleeding (including gingival/nasal/oral bleeding, skin \&soft tissue bleeding, gastrointestinal bleeding, urinary tract bleeding, cerebral haemorrhage, etc.) or bleeding tendency;
✓. Intolerance or rejection of long-term anti-coagulation therapy;
✓. Suffering stroke or embolism despite routine anti-coagulation therapy;
✓. With a predicting HAS-BLED score ≥3.

What they're measuring

Clinical success

Timeframe: 12-month

Trial details

NCT IDNCT04479722

SponsorShanghai MicroPort Medical (Group) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-27

View on ClinicalTrials.gov More Atrial Fibrillation trials