A Multinational Trial To Evaluate The Parachute Implant System (NCT01286116) | Clinical Trial Compass
TerminatedPhase 3
A Multinational Trial To Evaluate The Parachute Implant System
Stopped: Company closed
France, Germany, Latvia59 participantsStarted 2011-05
Plain-language summary
The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
. Subject is not hospitalized at time of enrollment.
. Diagnosis of heart failure for a minimum of 6 months prior to enrollment
. NYHA Class at time of enrollment, either:
. LVEF \>15% and ≤ 40% as measured by echocardiography.
. Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
. Eligible for cardiac surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE)
. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
. Cardiogenic shock within 72 hours of enrollment
. Revascularization procedure (PCI or CABG) within 60 days of enrollment
. Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
. Moderate aortic stenosis and regurgitation (aortic or mitral) \>2+.
. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
. A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.