INSPIRIS China PMCF Study

Aortic Valve Replacement Clinical Trial

— INSPIRIS China  

Official title:

Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05404880
• Other study ID #: 2021-09
• Status: Active, not recruiting
• Start date: July 13, 2022
• Est. completion date: December 2029

Study information

• Verified date: March 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 255
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement

Intervention

Device:
• EDWARDS INSPIRIS RESILIA Aortic Valve
Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Fuwai Hospital, CAMS & PUMC	Beijing	Beijing
China	Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of USTC (Anhui Provincial Hospital)	Hefei	Anhui
China	Fuwai Yunnan Cardiovascular Hospital	Kunming	Yunnan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen	Shenzhen	Guangdong
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xiamen Cardiovascular Hospital Xiamen University	Xiamen	Fujian
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
China	Henan Provincial Chest Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (4)

Lead Sponsor	Collaborator
Edwards Lifesciences	Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd., Fuwai Hospital, CAMS & PUMC, Rundo International Pharmaceutical Research & Development Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's Occurrence Rate of Study Valve Related Death	The primary safety endpoint is the percentage of study valve related death which includes death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death.	5 Years
Primary	Subject's Occurrence Rate of Structural Valve Deterioration	The primary safety endpoint is the percentage of Structural Valve Deterioration which includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by re-operation, autopsy, or clinical investigation.	5 Years
Primary	Subject's Occurrence Rate of Re-operation on the Study Valve	The primary safety endpoint is the reoperation rate on the study valve which is any operation that repairs, alters, or replaces the study valve, which occurs after the completion of the procedure and the transfer out of the procedure room.	5 Years
Primary	Subject's Occurrence Rate of Major Bleeding	The primary safety endpoint is the rate of major bleeding which is any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. Vision loss) or necessitates transfusion of 3 or more units of PRBC, pericardiocentesis, or exploration/reoperation for bleeding.	5 Years
Primary	Subject's Occurrence Rate of Thromboembolic Events	The primary safety endpoint is the rate of thromboembolic events which is an embolic event that occurs in absence of infection (endocarditis) starting from anesthesia time. Embolism may be manifested by a neurologic event (Stroke or Transient Ischemic Attack) or a non-cerebral embolic event.	5 Years
Primary	Subject's Occurrence Rate of Stroke	The primary safety endpoint is the rate of strokes which is a prolonged (>72 hours) or permanent neurologic deficit that is usually associated with abnormal results of magnetic resonance imaging or computed tomographic scans.	5 Years
Primary	Subject's Occurrence Rate of Transient Ischemic Attack	The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.	5 Years
Primary	Subject's Occurrence Rate of Non-Cerebral Thromboembolism	The primary safety endpoint is the rate of non-cerebral thromboembolism which is an embolus documented operatively, at autopsy, or clinically that produces signs or symptoms attributable to complete or partial obstruction of a peripheral artery (does not include deep vein thrombosis).	5 Years
Secondary	Subject's Average Mean Gradient at 5 Years	Hemodynamic performance - Mean gradients as evaluated by echocardiography	5 Years
Secondary	Subject's Average Peak Gradient at 5 Years	Hemodynamic performance - Peak gradients as evaluated by echocardiography	5 Years
Secondary	Subject's Average Effective Orifice Area at 5 Years	Hemodynamic performance - Effective Orifice Area evaluated by echocardiography	5 Years
Secondary	Subject's Average Effective Orifice Area Index at 5 Years	Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography	5 Years
Secondary	Amount of Aortic Central Regurgitation in Subjects at 5 Years	Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography	5 Years
Secondary	Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years	Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography	5 Years