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

Inclusion Criteria11

Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) > 65mm or left ventricular end-systolic dimension (LVESD) > 50mm;
Severe aortic valve regurgitation, and mean pressure gradient < 20mmHg; Annular perimeter ≤ 85 mm;
The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:
Severe aorta calcification or active ascending aorta atherosclerotic plaque
History of mediastinum radiotherapy
Past mediastinitis
Presence of unobstructed coronary bypass implants
Previous more than two cardiothoracic surgeries
Liver cirrhosis
Other surgical risk factors

Exclusion Criteria8

Age < 60 years old;
Ascending aorta diameter >45mm;
Coronary multi-vessel disease (SYNTAX score >32);
Life expectancy <1 year;
Left ventricular ejection fraction <30%;
Acute myocardial infarction within 30 days;
Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);
Other situations judged by the researcher as unsuitable for participating in the study.

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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.