NCT02240940

PARACHUTE China Approval Trial

PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CardioKinetix, Inc · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ischemic Heart Failure

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-05-01
• Completion: 2017-06-01
• First posted: 2014-09-16
• Last updated: 2017-06-22

Locations

7 sites across 1 country: China