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RecruitingNot ApplicableNCT04864145

Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation

Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study

Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

210 participants

Start Date

May 21, 2021

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Disease

Summary

Prospective, multicenter, randomized trial.

Eligibility

Min Age: 60 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Medical therapy and a medical device called Transcatheter Aortic Valve Implantation for people with aortic valve disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 60 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscatheter Aortic Valve Implantation

The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.

DRUGMedical therapy

Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.

Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT04864145

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