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

NCT04864145 | Recruiting DMC

• 1 other identifier: NFH20210325
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multicenter, randomized trial.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• Clinical worsening

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

  12 months

Secondary Outcomes (8)

• Procedural complications

  12 months

• 6-minute walk distance

  12 months

• New York Heart Association (NYHA) functional class

  12 months

• Stroke

  12 months

• Mortality

  12 months

Study Arms (2)

Medical therapy

ACTIVE COMPARATOR

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.

Drug: Medical therapy

Transcatheter Aortic Valve Implantation

EXPERIMENTAL

Patients in TAVR group will receive transcatheter aortic valve replacement.

Device: Transcatheter Aortic Valve Implantation

Interventions

Medical therapy DRUG

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

Also known as: Optimal medical therapy

Medical therapy

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.

Also known as: The VitaFlow™ system (MicroPort®, Shanghai, China)

Transcatheter Aortic Valve Implantation

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement; Nutrition Therapy

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Therapeutics

Study Officials

• Shao-Liang Chen, MD, PhD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Jun-Jie Zhang, MD, PhD

CONTACT

+86-25-52271350; jameszll@163.com

Jing Kan, MPH

CONTACT

+86-25-52271398; kanjingok@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 28, 2021
• Study Start: May 21, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)