A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02903420
• Collaborator: (none)
• Enrollment: 38
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 69.9
• Patients Per Site: 19
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis	Device: Transcatheter Aortic Valve Implantation (TAVI)	N/A

Detailed Description

1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 1, 2018
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAPIEN 3 Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System	Device: Transcatheter Aortic Valve Implantation (TAVI); Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.

Outcome Measures

Primary Outcome Measures

1. Mortality [1 year]

   Number of Deaths

Secondary Outcome Measures

1. Device Success [30 days]

   Number of patients with device success, defined as absence of procedural mortality, correct positioning of a study valve into the proper anatomical location, and intended performance of the study valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, and no moderate or severe prosthetic valve regurgitation).

2. Hospitalization Length of Stay [7 days]

   Discharge is defined as an average for 7 days

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.

• Patient has senile degenerative aortic valve stenosis

• Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.

• Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.

Exclusion Criteria:

• Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.

• Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.

• Patient has severe aortic valve regurgitation.

• Patient has severe mitral valve regurgitation.

• Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.

• Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osaka University Hospital	Suita	Osaka	Japan	565-0871
2	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan	160-8582

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Yoshiki Sawa, Osaka University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 6, 2020

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02903420
• Other Study ID Numbers: EW-P-003
• First Posted: Sep 16, 2016
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 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
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	Thirty-eight subjects were consented to the trial. Two subjects withdrawn from the study prior to the TAVI procedure. One subject had a gastrointestinal bleed prior to the procedure and the other subject had surgery per the decision of the surgeon.
Pre-assignment Detail	Eight of the 36 subjects were treated as "bailout" due to the non-nominal volumes. The primary analysis was performed on the patients with nominal volume (n=28).

Arm/Group Title	SAPIEN 3
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
Period Title: Overall Study
STARTED	28
COMPLETED	25
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	SAPIEN 3
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
Overall Participants	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	79.2 (5.2)
Sex: Female, Male (Count of Participants)
Female	9 32.1%
Male	19 67.9%
Race/Ethnicity, Customized (Count of Participants)
Japanese	28 100%
Region of Enrollment (participants) [Number]
Japan	28 100%
Duration of Dialysis (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	11.52 (10.47)
STS Score (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	14.34 (6.23)

Outcome Measures

1. Primary Outcome

Title	Mortality
Description	Number of Deaths
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAPIEN 3
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
Measure Participants	28
Count of Participants [Participants]	3 10.7%

2. Secondary Outcome

Title	Device Success
Description	Number of patients with device success, defined as absence of procedural mortality, correct positioning of a study valve into the proper anatomical location, and intended performance of the study valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, and no moderate or severe prosthetic valve regurgitation).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Echo data was missing for one patient.

Arm/Group Title	SAPIEN 3
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
Measure Participants	27
Count of Participants [Participants]	20 71.4%

3. Secondary Outcome

Title	Hospitalization Length of Stay
Description	Discharge is defined as an average for 7 days
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAPIEN 3
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
Measure Participants	28
Mean (Standard Deviation) [Days]	6.3 (2.2)

Adverse Events

Time Frame	1 year
Arm/Group Title	SAPIEN 3
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
All Cause Mortality
	SAPIEN 3
	Affected / at Risk (%)	# Events
Total	3/28 (10.7%)
Serious Adverse Events
	SAPIEN 3
	Affected / at Risk (%)	# Events
Total	17/28 (60.7%)
Cardiac disorders
Angina pectoris	1/28 (3.6%)	1
Angina unstable	1/28 (3.6%)	1
Arrhythmia supraventricular	1/28 (3.6%)	1
Atrioventricular block complete	2/28 (7.1%)	2
Cardiac failure	1/28 (3.6%)	1
Cardiac failure chronic	1/28 (3.6%)	1
Gastrointestinal disorders
Abdominal pain	1/28 (3.6%)	1
Gastrointestinal haemorrhage	2/28 (7.1%)	2
Large intestine polyp	1/28 (3.6%)	1
General disorders
Chest pain	1/28 (3.6%)	1
Infections and infestations
Pneumonia	1/28 (3.6%)	1
Sepsis	1/28 (3.6%)	1
Injury, poisoning and procedural complications
Femoral neck fracture	1/28 (3.6%)	1
Shunt occlusion	1/28 (3.6%)	1
Contusion	1/28 (3.6%)	1
Investigations
Blood pressure decreased	1/28 (3.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer	1/28 (3.6%)	1
Nervous system disorders
Carpal tunnel syndrome	1/28 (3.6%)	1
Cerebrovascular accident	2/28 (7.1%)	2
Dizziness	2/28 (7.1%)	2
Subarachnoid haematoma	1/28 (3.6%)	1
Vascular disorders
Hypertension	1/28 (3.6%)	1
Aortic rupture	1/28 (3.6%)	1
Peripheral arterial occlusive disease	2/28 (7.1%)	2
Other (Not Including Serious) Adverse Events
	SAPIEN 3
	Affected / at Risk (%)	# Events
Total	19/28 (67.9%)
Blood and lymphatic system disorders
Anaemia	4/28 (14.3%)	4
Cardiac disorders
Atrioventricular block first degree	2/28 (7.1%)	2
Bundle branch block left	7/28 (25%)	7
Gastrointestinal disorders
Constipation	2/28 (7.1%)	2
Nausea	2/28 (7.1%)	2
Vomiting	3/28 (10.7%)	3
General disorders
Pyrexia	3/28 (10.7%)	3
Injury, poisoning and procedural complications
Contusion	2/28 (7.1%)	2
Wound complication	2/28 (7.1%)	2
Shunt stenosis	4/28 (14.3%)	5
Metabolism and nutrition disorders
Diabetes mellitus	2/28 (7.1%)	2
Musculoskeletal and connective tissue disorders
Back pain	2/28 (7.1%)	2

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.