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RECRUITING
NCT04864145
NA

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

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

Summary

Prospective, multicenter, randomized trial.

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

Key Details

Gender

All

Age Range

60 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2021-05-21

Completion Date

2031-05-30

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DEVICE

Transcatheter 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.

DRUG

Medical 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