China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03466918
• Collaborator: (none)
• Enrollment: 58
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 63.3
• Patients Per Site: 14.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis; Symptomatic Aortic Stenosis; Aortic Regurgitation	Device: SAPIEN 3 THV with the Commander delivery system	N/A

Detailed Description

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.

A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
• Actual Study Start Date: May 23, 2018
• Actual Primary Completion Date: Jul 3, 2019
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with SAPIEN 3 THV Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system	Device: SAPIEN 3 THV with the Commander delivery system; Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system

Outcome Measures

Primary Outcome Measures

1. All-cause Mortality [30-days]

   All of the deaths that occurred in this population regardless of the cause.

Secondary Outcome Measures

1. Cardiovascular Mortality [30-days]

   All of the deaths that occurred in this population due to a cardiovascular issue.

2. Non-Cardiovascular Mortality [30-days]

   All of the deaths that occurred in this population due to a non-cardiovascular issue.

3. Number of Participants With a Stroke [30-days]

   Total number of participates with a stroke.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.

2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.

3. NYHA Functional Class II or greater.

4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.

5. The study patient agrees to comply with all required postprocedure follow-up visits.

Exclusion Criteria:

1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.

2. Aortic valve is a congenital unicuspid or is non-calcified.

3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).

4. Anomalous coronary artery that would interfere with proper placement of the valve.

5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital, CAMS&PUMC	Beijing		China
2	WestChina Hospital, Sichuan University	Chengdu		China
3	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou		China
4	Zhongshan Hospital Fudan University	Shanghai		China

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Prof Junbo GE, Zhongshan Hospital and Fudan University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 22, 2017

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT03466918
• Other Study ID Numbers: 2017-08
• First Posted: Mar 15, 2018
• Last Update Posted: Sep 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Edwards Lifesciences: TAVI; TAVR; CHINA; SAPIEN 3; High Risk; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	Each study site was allowed up to two roll-in patients. Per the protocol, roll-in patients completed all study visits and procedures but were not part of the analysis. Eight of the 58 patients enrolled were roll-in patients.

Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Period Title: Overall Study
STARTED	58
Analysis Population	50
COMPLETED	58
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.8 (6.07)
Sex: Female, Male (Count of Participants)
Female	23 46%
Male	27 54%
Race/Ethnicity, Customized (Count of Participants)
Chinese	50 100%
Region of Enrollment (Count of Participants)
China	50 100%
STS Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.0 (2.77)
NYHA Class Grouped (Count of Participants)
Class I/II	9 18%
Class III/IV	41 82%

Outcome Measures

1. Primary Outcome

Title	All-cause Mortality
Description	All of the deaths that occurred in this population regardless of the cause.
Time Frame	30-days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Measure Participants	50
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Cardiovascular Mortality
Description	All of the deaths that occurred in this population due to a cardiovascular issue.
Time Frame	30-days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Measure Participants	50
Count of Participants [Participants]	0 0%

3. Secondary Outcome

Title	Non-Cardiovascular Mortality
Description	All of the deaths that occurred in this population due to a non-cardiovascular issue.
Time Frame	30-days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients will be implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Measure Participants	50
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Number of Participants With a Stroke
Description	Total number of participates with a stroke.
Time Frame	30-days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Measure Participants	50
Count of Participants [Participants]	1 2%

Adverse Events

Time Frame	30-days
Adverse Event Reporting Description	All Adverse Events are site-reported.
Arm/Group Title	Patients With SAPIEN 3 THV
Arm/Group Description	Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
All Cause Mortality
	Patients With SAPIEN 3 THV
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	Patients With SAPIEN 3 THV
	Affected / at Risk (%)	# Events
Total	13/50 (26%)
Blood and lymphatic system disorders
Pancytopenia	1/50 (2%)	1
Cardiac disorders
Cardiac arrest	2/50 (4%)	2
Atrioventricular block complete	1/50 (2%)	1
Cardiac failure	1/50 (2%)	1
Cardiac failure acute	1/50 (2%)	1
Coronary artery occlusion	1/50 (2%)	1
Ventricular flutter	1/50 (2%)	1
Ventricular tachycardia	1/50 (2%)	1
Infections and infestations
Lung infection	1/50 (2%)	1
Injury, poisoning and procedural complications
Femoral neck fracture	1/50 (2%)	1
Vascular access site occlusion	1/50 (2%)	1
Vascular pseudoaneurysm	1/50 (2%)	1
Investigations
Platelet count decreased	1/50 (2%)	2
Metabolism and nutrition disorders
Diabetes mellitus	1/50 (2%)	1
Nervous system disorders
Dizziness	1/50 (2%)	1
Ischaemic stroke	1/50 (2%)	1
Vascular disorders
Deep vein thrombosis	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Patients With SAPIEN 3 THV
	Affected / at Risk (%)	# Events
Total	48/50 (96%)
Blood and lymphatic system disorders
Thrombocytopenia	13/50 (26%)	13
Anaemia	4/50 (8%)	4
Leukocytosis	3/50 (6%)	3
Cardiac disorders
Bundle branch block left	7/50 (14%)	7
Atrial fibrillation	4/50 (8%)	4
Atrioventricular block first degree	3/50 (6%)	3
Gastrointestinal disorders
Constipation	4/50 (8%)	4
General disorders
Pyrexia	6/50 (12%)	6
Oedema peripheral	4/50 (8%)	4
Infections and infestations
Lung infection	3/50 (6%)	3
Injury, poisoning and procedural complications
Procedural haemorrhage	12/50 (24%)	12
Vascular access site haemorrhage	8/50 (16%)	9
Post procedural fever	7/50 (14%)	7
Post procedural constipation	3/50 (6%)	3
Investigations
Fibrin D dimer increased	17/50 (34%)	17
Troponin T increased	16/50 (32%)	16
Troponin increased	9/50 (18%)	9
Blood glucose increased	3/50 (6%)	3
Renal and urinary disorders
Haematuria	3/50 (6%)	3
Respiratory, thoracic and mediastinal disorders
Epistaxis	3/50 (6%)	3
Haemoptysis	3/50 (6%)	3
Skin and subcutaneous tissue disorders
Ecchymosis	3/50 (6%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Without the Sponsor's prior written consent, the Principal Investigator shall not publish the clinical study results or any documents containing any Study information at any academic conferences or in any publications of any nature.