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

Heart Failure Clinical Trial

— P5  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02543632
• Other study ID #: RD1591
• Status: Terminated
• Phase: N/A
• First received: September 4, 2015
• Last updated: June 21, 2017
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: CardioKinetix, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Left Ventricular Dysfunction
• Myocardial Ischemia
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Parachute Implant System
The CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle.

Locations

Country	Name	City	State
Germany	Uniklinik Aachen	Aachen
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim
Germany	Unfalkrankenhaus Berlin	Berlin
Germany	University Köln	Cologne
Germany	Cardiac Research GmbH	Dortmund	Hohe Straße 1
Germany	Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie	Düsseldorf	Moorenstr. 5
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie	Essen	Klara-Kopp-Weg 1
Germany	Asklepios Klinik St. George	Hamburg
Germany	Universitäres Herzzentrum Hamburg Eppendorf GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
CardioKinetix, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	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.	6 months
Secondary	Stroke Volume Index	An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.	0 days (at implant)