Health TrialsbyHealthPanel

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

ConditionAortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

Prospective, multicenter, randomized trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Severe aorta calcification or active ascending aorta atherosclerotic plaque

Disqualifiers

Age < 60 years old;

Ascending aorta diameter >45mm;

Coronary multi-vessel disease (SYNTAX score >32);

Life expectancy <1 year;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcatheter Aortic Valve Implantation

    Device

    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.

  • Medical therapy

    Drug

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

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Medical therapyActive comparator 1 intervention
Group B: Transcatheter Aortic Valve ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical worsening

A composite of all cause death, disabling stroke, or heart failure rehospitalization

Time frame
12 months

Secondary outcomes

1

Procedural complications

Any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation.

Time frame
12 months
2

6-minute walk distance

This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

Time frame
12 months
3

New York Heart Association (NYHA) functional class

Classification of function capacity of the NYHA.

Time frame
12 months
4

Stroke

Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing First Hospital, Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov
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