PARACHUTE China Approval Trial

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02240940
Study type	Interventional
Source	CardioKinetix, Inc
Contact
Status	Terminated
Phase	N/A
Start date	September 2014
Completion date	June 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00846001` - Resynchronization Surgery Combined Unified Efficacy	Phase 3
Recruiting	`NCT05566600` - Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure	Early Phase 1
Active, not recruiting	`NCT01961726` - Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure	Phase 1/Phase 2
Terminated	`NCT00102128` - Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.	Phase 2
Not yet recruiting	`NCT03491969` - Clinical Study of Lipoic Acid on Ischemic Heart Failure	Phase 4
Recruiting	`NCT01555320` - Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure	N/A
Recruiting	`NCT02875639` - A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)	Phase 2
Completed	`NCT02700880` - LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry
Active, not recruiting	`NCT01643590` - Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure.	Phase 2
Active, not recruiting	`NCT02115568` - Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203	N/A
Recruiting	`NCT03206593` - Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure	N/A
Enrolling by invitation	`NCT01709279` - Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure	N/A
Not yet recruiting	`NCT06258447` - CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.