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

Terminated

• Conditions: Left Ventricular Dysfunction; Heart Failure
• Interventions: Device: Parachute Implant System

• Registration Number: NCT02543632
• Lead Sponsor: CardioKinetix, Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quality of Life	6 months	An improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline (day -1) using the Minnesota Living with Heart Failure (MLWHF) Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Stroke Volume Index	0 days (at implant)	An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.

Trial Locations

Locations (10)

Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie; 🇩🇪 Essen, Klara-Kopp-Weg 1, Germany

Cardiac Research GmbH; 🇩🇪 Dortmund, Hohe Straße 1, Germany

Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie; 🇩🇪 Düsseldorf, Moorenstr. 5, Germany

Kerckhoff-Klinik gGmbH; 🇩🇪 Bad Nauheim, Germany

Uniklinik Aachen; 🇩🇪 Aachen, Germany

Unfalkrankenhaus Berlin; 🇩🇪 Berlin, Germany

University Köln; 🇩🇪 Cologne, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Asklepios Klinik St. George; 🇩🇪 Hamburg, Germany

Universitäres Herzzentrum Hamburg Eppendorf GmbH; 🇩🇪 Hamburg, Germany