Overview

This trial is active, not recruiting.

Condition ischemic heart failure
Treatment parachute implant
Sponsor CardioKinetix, Inc
Collaborator Guangzhou Chuangsi Medical Technology Co., Ltd.
Start date September 2014
End date May 2015
Trial size 30 participants
Trial identifier NCT02240940, RD1735

Summary

The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system. The purpose of this trial is to use the Parachute percutaneous left ventricular partitioning system to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease and provide the data required to gain Chinese regulatory approval.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI.
parachute implant
CardioKinetix's Parachute implant device is suitable for use in isolating the dysfunctional region of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. Potential benefits of the Parachute implant device are improvement in hemodynamics and the clinical symptoms of heart failure.

Primary Outcomes

Measure
Reduction of LVESVi
time frame: 3 months

Secondary Outcomes

Measure
Major Adverse Cardiac Events
time frame: 3 months
Improvement in NYHA Class
time frame: 3 months
Improvement in 6 minute walk test
time frame: 3 months
Improvement in Quality of Life
time frame: 3 months
Procedural Success
time frame: Day 0

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

Inclusion Criteria: - Age ≥ 18 years ≤ 79 years - BMI < 40` - Left ventricle ejection fraction ≤40% and ≥15% - Previous transthoracic echocardiography showing LV MI structural heart dysfunction represented by LV wall motion abnormalities (WMA) - Appearance of ischemic heart failure symptoms (NYHA class II to "nonhospitalized" class IV) following anterior wall infarction and within the previous 60 days - Left ventricle must have the appropriate anatomical structures (size and shape); cardiac CT and left ventricular angiography are used to confirm that implanting an appropriate Parachute device is possible - Have received appropriate treatment according to ACC/AHA guidelines - Subject or his/her legal representative informed of the nature of the study and consented to participate in all the provisions of the trial, signed the EC-approved informed consent form, agreed to undergo the post-surgery treatment plan and follow-up requirements, and is able to complete the follow-up and required follow-up examinations. Exclusion Criteria: - Significant ventricle wall motion abnormalities in addition to the anteroapical region - Valvular stenosis or regurgitation (tricuspid, aortic, or mitral valve) > 2+ - Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) - Requires long-term dialysis for end-stage renal disease or onset of sepsis or active endocarditis - Life expectancy at time of enrollment and hospitalization <1 year - Known allergies or contraindications to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast agents, that cannot be sufficiently treated with medication before surgery - Cardiogenic shock within 72 hours of screening - Pregnant or planning to become pregnant during the study period - Participated in a clinical trial of another drug or medical device within 30 days of screening - The researchers have determined that patient compliance is poor and that the person will be unable to complete the study in accordance with the requirements

Additional Information

Official title PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System
Principal investigator Yuejin Yang, MD
Description CardioKinetix has developed a catheter-based treatment method that can be used for treating patients with heart failure due to ischemic heart disease (left ventricle enlargement after anterior wall myocardial infarction). This implant device, called the "Parachute," is a partitioning membrane placed inside the apex of an enlarged ventricle with motion abnormalities. The Parachute implant device can then isolate the dysfunctional apex region in the ventricle, reduce ventricular volume, and improve left ventricular diastolic compliance. Patients approved for enrollment after screening by cardiac CT or MRI will be implanted with a Parachute implant device (the study device). Patients will receive all appropriate medical therapy (AAMT) approved by their physician. The patient cohort will include patients with heart failure who have wall motion abnormalities due to previous myocardial infarction, left ventricular ejection fraction ≤40% and ≥15%, and NYHA class II - IV(non-hospitalized). A maximum of 30 patients will be enrolled at seven centers. Patients who have passed screening with transthoracic echocardiography (TTE) and cardiac CT or MRI will be enrolled in the trial. After confirming that a patient meets the enrollment qualifications with cardiac CT or MRI evaluation, the patient will be enrolled in the trial and will be implanted with a Parachute device and treated with warfarin/aspirin anticoagulation therapy. In the follow-up periods 3 months, 6 months, and 1 year after surgery, clinical evaluation, TTE testing, functional assessment, 6-minute walk test, and evaluation of adverse events will be done.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by CardioKinetix, Inc.