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

Aortic Valve Disease Clinical Trial

— SEASON-AR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864145
• Other study ID #: NFH20210325
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: May 30, 2031

Study information

• Verified date: March 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jun-Jie Zhang, MD, PhD
• Phone: +86-25-52271350
• Email: jameszll[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, randomized trial.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 30, 2031
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

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