Paravalvular Leak clinical trials

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.

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NCT ID: NCT05506293 Recruiting - Quality of Life Clinical Trials

European Multicentre Registry of Percutaneous Paravalvular Leak Closure

EuroPVL

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis. Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.