Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure (MVLV)

Abbott

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: CRT

Study type: Observational

Funder types: Industry

Identifiers

NCT02367716

SJM- CIP-CRD 733

Details and patient eligibility

About

The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).

Full description

This is a multi-center, non-randomized observational study.

The total duration of the study is expected to be 2.5 years. The clinical study will be conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in this study. Subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. All subjects need to be followed for at least 6 months.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets the current European Society of Cardiology (ESC) or American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS) Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber Implantable Cardioverter-Defibrillators (ICDs))
• Are ≥ 18 years of age at the time of enrolment.
• Are able to provide written Informed Consent prior to any study related procedure.

Exclusion criteria

• Patient who is unable to comply with the follow-up schedule.
• Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study .
• Patient has a life expectancy of less than 1 year due to any condition.
• Patients, who has a CRT device implanted