UnknownNot Applicable

ChordArt System for Mitral Regurgitation

Lithuania5 participantsStarted 2018-03-21

Plain-language summary

The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.

Who can participate

Age range

18 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: * Age ≥ 18 years * Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail * Left Ventricular Ejection Fraction \>20% * New York Heart Association functional class II to IV * Able and willing to give informed consent and follow protocol procedures. Exclusion Criteria: * Life expectancy \<1 year * Hemodynamic instability * Severe untreated ischemic disease * Pulmonary Hypertension * Any prior mitral valve surgery or transcatheter mitral valve procedure * Stroke or transient ischemic event within 30 days before randomization * Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating. * Renal insufficiency * Acute anemia * Chronic obstructive pulmonary disease * Severe right ventricular dysfunction * Hepatic insufficiency * Patient is participating in other investigational studies

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

All-cause mortality

Timeframe: At 30 days from implant procedure

Major adverse events

Timeframe: At 30 days from implant procedure

Trial details

NCT IDNCT03581656

SponsorCoreMedic GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-10

View on ClinicalTrials.gov More Mitral Valve Repair trials

Who can participate

Age range

18 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.