Hong Kong and Taiwan HM3 PMS

Abbott

Status: Terminated

Conditions: Advanced Heart Failure

Treatments: Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04703855

CRD 1022 (Other Identifier)

ABT-CIP-10382

Details and patient eligibility

About

Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.

Exclusion Criteria: None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

HeartMate 3™ left ventricular assist system (HM3 LVAS)

Experimental group

Description:

Patients will be implanted with the HM3 LVAS

Treatment:

Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)