Clinical trial NCT05404880: INSPIRIS China PMCF Study
Official title: Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
name: Rundo International Pharmaceutical Research & Development Co.,Ltd.
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2022-06-03
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects requiring an elective replacement of their native or prosthetic aortic valve who have agreed to participate in the study.

Brief summary: The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.

Detailed description: The trial is a multi-center, prospective, single-arm study that will enroll up to 250 subjects. The study is being divided into 2 stages: Stage 1 is enrollment and 5 years of follow-up after implantation. Stage 2 is additional follow-up through 10 years upon authority's feedback if needed.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
4. Provide signed informed consent prior to the study participation

Exclusion Criteria:

1. Valve implantation is contraindicated per the IFU
2. Requires planned multiple valve replacement/ repair
3. Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
4. Estimated Life expectancy\< 12 months
5. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

Primary outcomes:
measure: Subject's Occurrence Rate of Study Valve Related Death
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Structural Valve Deterioration
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Re-operation on the Study Valve
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Major Bleeding
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Thromboembolic Events
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Stroke
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Transient Ischemic Attack
timeFrame: 5 Years
measure: Subject's Occurrence Rate of Non-Cerebral Thromboembolism
timeFrame: 5 Years
Secondary outcomes:
measure: Subject's Average Mean Gradient at 5 Years
timeFrame: 5 Years
measure: Subject's Average Peak Gradient at 5 Years
timeFrame: 5 Years
measure: Subject's Average Effective Orifice Area at 5 Years
timeFrame: 5 Years
measure: Subject's Average Effective Orifice Area Index at 5 Years
timeFrame: 5 Years
measure: Amount of Aortic Central Regurgitation in Subjects at 5 Years
timeFrame: 5 Years
measure: Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years
timeFrame: 5 Years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital, CAMS & PUMC
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial Chest Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
state: Sichuan
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Hansong Sun, Professor
role: PRINCIPAL_INVESTIGATOR
References: