Clinical trial NCT02543632: PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.
Official title: PARACHUTE V: PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. A German Trial to Evaluate the Improvement in Quality of Life and Cardiac Output Following Implanting of the Parachute Implant System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Left Ventricular Dysfunction
Keywords: heart failure
parachute
partitioning device
Lead sponsor: CardioKinetix, Inc
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 18 years of age with symptoms of heart failure and anteroapical wall motion abnormality due to myocardial infarction.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Stroke Volume Index
timeFrame: 0 days (at implant)
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Cardiac Research GmbH
state: Hohe Straße 1
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie
state: Klara-Kopp-Weg 1
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
state: Moorenstr. 5
city: Aachen
country: Germany
facility: Uniklinik Aachen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Unfalkrankenhaus Berlin
city: Cologne
country: Germany
facility: University Köln
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. George
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg Eppendorf GmbH
Study officials:
affiliation: Kerckhoff Klinik
name: Helge Möllmann, MD
role: PRINCIPAL_INVESTIGATOR
References: