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

Primary Purpose

Aortic Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcatheter Aortic Valve Implantation
Medical therapy
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Medical therapy

Transcatheter Aortic Valve Implantation

Arm Description

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.

Patients in TAVR group will receive transcatheter aortic valve replacement.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2021
Last Updated
June 30, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04864145
Brief Title
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Acronym
SEASON-AR
Official Title
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
May 30, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Transcatheter Aortic Valve Implantation
Arm Type
Experimental
Arm Description
Patients in TAVR group will receive transcatheter aortic valve replacement.
Intervention Type
Device
Intervention Name(s)
Transcatheter Aortic Valve Implantation
Other Intervention Name(s)
The VitaFlow™ system (MicroPort®, Shanghai, China)
Intervention Description
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
Drug
Intervention Name(s)
Medical therapy
Other Intervention Name(s)
Optimal medical therapy
Intervention Description
Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
Primary Outcome Measure Information:
Title
Clinical worsening
Description
A composite of all cause death, disabling stroke, or heart failure rehospitalization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedural complications
Description
Any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation.
Time Frame
12 months
Title
6-minute walk distance
Description
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time Frame
12 months
Title
New York Heart Association (NYHA) functional class
Description
Classification of function capacity of the NYHA.
Time Frame
12 months
Title
Stroke
Description
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.
Time Frame
12 months
Title
Mortality
Description
All-cause, cardiovascular, and non-cardiovascular mortality
Time Frame
12 months
Title
Bleeding Complications
Description
The original VARC definitions with BARC classifications
Time Frame
12 months
Title
Prothetic valve dysfunction
Description
Any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
Time Frame
12 months
Title
Rehospitalization
Description
Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Jie Zhang, MD, PhD
Phone
+86-25-52271350
Email
jameszll@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Kan, MPH
Phone
+86-25-52271398
Email
kanjingok@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD, PhD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Phone
+86 13605157029
Email
chmengx@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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