TerminatedNot Applicable

Amplatzer Amulet China Post Market Study (PMS)

Stopped: This study was terminated due to the shift in Sponsor's business strategy.

China50 participantsStarted 2024-01-30

Plain-language summary

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
✓. Meets the current device indications and per physician discretion for Amulet implant
✓. Able to provide written Informed Consent prior to any study related procedures
✓. 18 years of age or older at the time of enrolment

Exclusion criteria

✕. With the presence of intracardiac thrombus
✕. With active endocarditis or other infections producing bacteremia
✕. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score \< 3)
✕. Where placement of the device would interfere with any intracardiac or intravascular structures
✕. Has a life expectancy of less than 2 years due to any condition
✕. Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial

What they're measuring

Occurrence of major adverse events

Timeframe: 7 days

Occurrence of device embolization,device erosion,clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections(endocarditis and pericarditis), device breakage, or device related allergy

Timeframe: 2 years

Composite of ischemic stroke or systemic embolism

Timeframe: 2 years

Trial details

NCT IDNCT06189365

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-05

View on ClinicalTrials.gov More Non-Valvular Atrial Fibrillation trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
✓. Meets the current device indications and per physician discretion for Amulet implant
✓. Able to provide written Informed Consent prior to any study related procedures
✓. 18 years of age or older at the time of enrolment

Exclusion criteria

✕. With the presence of intracardiac thrombus
✕. With active endocarditis or other infections producing bacteremia
✕. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score \< 3)
✕. Where placement of the device would interfere with any intracardiac or intravascular structures
✕. Has a life expectancy of less than 2 years due to any condition
✕. Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial

What they're measuring

Occurrence of major adverse events

Timeframe: 7 days

Timeframe: 2 years

Composite of ischemic stroke or systemic embolism

Timeframe: 2 years