UnknownNot Applicable

Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

Germany20 participantsStarted 2021-03-01

Plain-language summary

The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.

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: * Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team. * Signs and symptoms of left-sided heart failure. * Left-ventricular ejection fraction ≥50% * Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure \[PCWP\] or left-ventricular end-diastolic pressure ≥15 mmHg) Exclusion Criteria: * Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment * Moderate aortic stenosis. * Pregnancy * Contraindication to perform cardiac magnetic resonance imaging. * Conditions rendering patient unable to give informed consent to the study protocol.

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

Periprocedural change in enddiastolic pressure volume relationship of the left ventricle

Timeframe: Periprocedural.

Trial details

NCT IDNCT04782908

SponsorHeart Center Leipzig - University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-30

Contact for this trial

Karl-Patrik Kresoja, MD

0341865252596 karl-patrik.kresoja@medizin.uni-leipzig.de

View on ClinicalTrials.gov More Congestive Heart Failure trials