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Recruiting NCT04864145

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

No phase Interventional Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Aortic Valve Implantation, Medical therapy.
Who it may be relevant to
Registry conditions: Aortic Valve Disease. Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Prospective, multicenter, randomized trial.

Detailed description

Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro Heart Survey, only 21.8% with LVEF 30-50% and 2.7% with LVEF \<30% were referred for surgical aortic valve replacement (SAVR) among patients with severe native aortic regurgitation. Advanced age and comorbidities were often considered as main reasons to refuse SAVR. The annual mortality of untreated patients with severe AR is 10-20%. Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (TAVR) because the specific anatomical features can preclude adequate valve implantation. Several small, retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR. The present study aims to investigate the use of TAVR in AR patients.

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.

Primary outcome measures

  • Clinical worsening [Time frame: 12 months]
Secondary outcome measures (8)
  • Procedural complications [Time frame: 12 months]
  • 6-minute walk distance [Time frame: 12 months]
  • New York Heart Association (NYHA) functional class [Time frame: 12 months]
  • Stroke [Time frame: 12 months]
  • Mortality [Time frame: 12 months]
  • Bleeding Complications [Time frame: 12 months]
  • Prothetic valve dysfunction [Time frame: 12 months]
  • Rehospitalization [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing First Hospital — Nanjing

Identifiers

NCT: NCT04864145 · NFH20210325

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗