Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation (SEASON-AR)

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

Prospective, multicenter, randomized trial.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Drug: Medical therapy; Device: Transcatheter Aortic Valve Implantation

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 Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun-Jie Zhang, MD, PhD; Phone Number: +86-25-52271350; Email: jameszll@163.com
• Study Contact Backup: Name: Jing Kan, MPH; Phone Number: +86-25-52271398; Email: kanjingok@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Shaoliang Chen, MD; Phone Number: +86 13605157029; Email: chmengx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Medical therapy; Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.; Other Names: Optimal medical therapy
Experimental: Transcatheter Aortic Valve Implantation; Patients in TAVR group will receive transcatheter aortic valve replacement.	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.; Other Names: The VitaFlow™ system (MicroPort®, Shanghai, China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical worsening	A composite of all cause death, disabling stroke, or heart failure rehospitalization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural complications	Any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation.	12 months
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.	12 months
New York Heart Association (NYHA) functional class	Classification of function capacity of the NYHA.	12 months
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.	12 months
Mortality	All-cause, cardiovascular, and non-cardiovascular mortality	12 months
Bleeding Complications	The original VARC definitions with BARC classifications	12 months
Prothetic valve dysfunction	Any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation	12 months
Rehospitalization	Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure.	12 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Shao-Liang Chen, MD, PhD, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2031

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease; Therapeutics; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement; Nutrition Therapy
• Other Study ID Numbers: NFH20210325

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No