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

Not Applicable

Recruiting

• Conditions: Aortic Valve Disease
• Interventions: Drug: Medical therapy; Device: Transcatheter Aortic Valve Implantation

• Registration Number: NCT04864145
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-04-24
• Study First Submitted QC: 2021-04-24
• Study First Posted: 2021-04-28
• Study Start: 2021-05-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-05-30
• Study Completion: 2031-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. 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;

2. Severe aortic valve regurgitation, and mean pressure gradient < 20mmHg; Annular perimeter ≤ 85 mm;

3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;

4. 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:

   1. Severe aorta calcification or active ascending aorta atherosclerotic plaque
   2. History of mediastinum radiotherapy
   3. Past mediastinitis
   4. Presence of unobstructed coronary bypass implants
   5. Previous more than two cardiothoracic surgeries
   6. Liver cirrhosis
   7. Other surgical risk factors

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical therapy	Medical therapy	Patients in medical therapy will receive conservative care, mainly including angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
Transcatheter Aortic Valve Implantation	Transcatheter Aortic Valve Implantation	Patients in TAVR group will receive transcatheter aortic valve replacement.

Primary Outcome Measures

Name	Time	Method
Clinical worsening	12 months	A composite of all cause death, disabling stroke, or heart failure rehospitalization

Secondary Outcome Measures

Name	Time	Method
Prothetic valve dysfunction	12 months	Any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
Rehospitalization	12 months	Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure.
New York Heart Association (NYHA) functional class	12 months	Classification of function capacity of the NYHA.
Mortality	12 months	All-cause, cardiovascular, and non-cardiovascular mortality
Bleeding Complications	12 months	The original VARC definitions with BARC classifications
Procedural complications	12 months	Any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation.
6-minute walk distance	12 months	This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Stroke	12 months	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.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China