CompletedPhase 2

Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery

Germany, Poland11 participantsStarted 2009-02

Plain-language summary

This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular restoration in patients with dilated cardiomyopathy who are scheduled to undergo routine open heart surgery. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure. This clinical evaluation is intended to provide the initial evidence of the safety and feasibility of the device as well as the procedure used to deploy the device. The results of the initial trial will also help to establish the utility of various assessments in evaluating and following the effects of the device.

Who can participate

Age range

18 Years – 75 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

. The patients must be able and willing to give written informed consent.
. The patients will be adult (age ≥ 18 years and \</= 75 years) males or females who are scheduled to undergo open-chest coronary artery bypass grafting surgery and/or valve repair/replacement.
. The patients must be on stable, evidence-based therapy for heart failure.
. The patients will have an ejection fraction equal to or less than 40% and a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA).
. Patients must have symptomatic heart failure with a New York Heart Association (NYHA) class of III or IV
. If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device.

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

Freedom from serious adverse events

Timeframe: 6 months

Trial details

NCT IDNCT00847964

SponsorLoneStar Heart, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

View on ClinicalTrials.gov More Dilated Cardiomyopathy trials

Plain-language summary

Who can participate

Age range

18 Years – 75 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

. The patients must be able and willing to give written informed consent.
. The patients will be adult (age ≥ 18 years and \</= 75 years) males or females who are scheduled to undergo open-chest coronary artery bypass grafting surgery and/or valve repair/replacement.
. The patients must be on stable, evidence-based therapy for heart failure.
. The patients will have an ejection fraction equal to or less than 40% and a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA).
. Patients must have symptomatic heart failure with a New York Heart Association (NYHA) class of III or IV
. If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device.

Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria