PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. (P5)

CardioKinetix

Status: Terminated

Conditions: Heart Failure; Left Ventricular Dysfunction

Treatments: Device: Parachute Implant System

Study type: Observational

Funder types: Industry

Identifiers

NCT02543632

RD1591

Details and patient eligibility

About

Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.

Full description

Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA)
• Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%)
• Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines
• >18 years of age
• Provide written informed consent
• Agree to the protocol-required follow-up

Exclusion criteria

• Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment
• Cardiogenic shock within 72 hours of enrollment
• A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated
• Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy).
• Co-morbidities associated with a life expectancy of less than 12-months
• Treatment Arm only (Control Arm excluded from this criteria): Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by magnetic resonance imaging (MRI) or computerized tomography (CT). (Characteristics include inappropriate size and shape of the left ventricle, pseudo chordae or trabeculations interfering with device placement.)

Trial design

85 participants in 2 patient groups

Treated group

Description:

Subjects who meet the inclusion/exclusion criteria listed and also are approved via anatomical inclusion criteria for treatment with the Parachute Implant System.

Treatment:

Device: Parachute Implant System

Control group

Description:

Subjects who meet the inclusion/exclusion criteria listed and also are are excluded for treatment with the Parachute Implant System due to anatomical characteristics such as obstructing pseudochordae, calcification, or wall thickness.