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

NCT ID: NCT04864145

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2031-05-30

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.

Conditions

Aortic Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Medical therapy

Intervention Type: DRUG

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

Patients in TAVR group will receive transcatheter aortic valve replacement.

Group Type: EXPERIMENTAL

Transcatheter Aortic Valve Implantation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Medical therapy

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

Intervention Type: DRUG

Other Intervention Names

The VitaFlow™ system (MicroPort®, Shanghai, China); Optimal medical therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shaoliang Chen, MD

Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shao-Liang Chen, MD, PhD

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun-Jie Zhang, MD, PhD

Role: CONTACT

jameszll@163.com

+86-25-52271350

Jing Kan, MPH

Role: CONTACT

kanjingok@126.com

+86-25-52271398

Facility Contacts

Shaoliang Chen, MD

Role: primary

chmengx@126.com

+86 13605157029

Other Identifiers

NFH20210325

Identifier Type: -

Identifier Source: org_study_id