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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04864145
Other study ID # NFH20210325
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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