Trial Outcomes & Findings for A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) (NCT NCT02903420)

NCT ID: NCT02903420

Last Updated: 2024-09-25

Results Overview

Number of Deaths

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-09-25

Participant Flow

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 Two subjects withdrawn from the study prior to the TAVI procedure.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.

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).

Participant milestones

Measure	SAPIEN 3 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 Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	SAPIEN 3 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 Study Death	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SAPIEN 3 n=28 Participants 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.
Age, Continuous	79.2 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	28 Participants n=5 Participants
Region of Enrollment Japan	28 participants n=5 Participants
Duration of Dialysis	11.52 Years STANDARD_DEVIATION 10.47 • n=5 Participants
STS Score	14.34 Units on a Scale STANDARD_DEVIATION 6.23 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Number of Deaths

Outcome measures

Measure	SAPIEN 3 n=28 Participants 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.
Mortality	3 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Echo data was missing for one patient.

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).

Outcome measures

Measure	SAPIEN 3 n=27 Participants 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.
Device Success	20 Participants

SECONDARY outcome

Timeframe: 7 days

Discharge is defined as an average for 7 days

Outcome measures

Measure	SAPIEN 3 n=28 Participants 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.
Hospitalization Length of Stay	6.3 Days Standard Deviation 2.2

Adverse Events

SAPIEN 3

Serious events: 17 serious events

Other events: 19 other events

Deaths: 3 deaths

Serious adverse events

Measure	SAPIEN 3 n=28 participants at risk 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.
Cardiac disorders Angina pectoris	3.6% 1/28 • Number of events 1 • 1 year
Cardiac disorders Angina unstable	3.6% 1/28 • Number of events 1 • 1 year
Cardiac disorders Arrhythmia supraventricular	3.6% 1/28 • Number of events 1 • 1 year
Cardiac disorders Atrioventricular block complete	7.1% 2/28 • Number of events 2 • 1 year
Cardiac disorders Cardiac failure	3.6% 1/28 • Number of events 1 • 1 year
Cardiac disorders Cardiac failure chronic	3.6% 1/28 • Number of events 1 • 1 year
Gastrointestinal disorders Abdominal pain	3.6% 1/28 • Number of events 1 • 1 year
Gastrointestinal disorders Gastrointestinal haemorrhage	7.1% 2/28 • Number of events 2 • 1 year
Gastrointestinal disorders Large intestine polyp	3.6% 1/28 • Number of events 1 • 1 year
General disorders Chest pain	3.6% 1/28 • Number of events 1 • 1 year
Infections and infestations Pneumonia	3.6% 1/28 • Number of events 1 • 1 year
Infections and infestations Sepsis	3.6% 1/28 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Femoral neck fracture	3.6% 1/28 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Shunt occlusion	3.6% 1/28 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Contusion	3.6% 1/28 • Number of events 1 • 1 year
Investigations Blood pressure decreased	3.6% 1/28 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	3.6% 1/28 • Number of events 1 • 1 year
Nervous system disorders Carpal tunnel syndrome	3.6% 1/28 • Number of events 1 • 1 year
Nervous system disorders Cerebrovascular accident	7.1% 2/28 • Number of events 2 • 1 year
Nervous system disorders Dizziness	7.1% 2/28 • Number of events 2 • 1 year
Nervous system disorders Subarachnoid haematoma	3.6% 1/28 • Number of events 1 • 1 year
Vascular disorders Hypertension	3.6% 1/28 • Number of events 1 • 1 year
Vascular disorders Aortic rupture	3.6% 1/28 • Number of events 1 • 1 year
Vascular disorders Peripheral arterial occlusive disease	7.1% 2/28 • Number of events 2 • 1 year

Other adverse events

Measure	SAPIEN 3 n=28 participants at risk 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.
Blood and lymphatic system disorders Anaemia	14.3% 4/28 • Number of events 4 • 1 year
Cardiac disorders Atrioventricular block first degree	7.1% 2/28 • Number of events 2 • 1 year
Cardiac disorders Bundle branch block left	25.0% 7/28 • Number of events 7 • 1 year
Gastrointestinal disorders Constipation	7.1% 2/28 • Number of events 2 • 1 year
Gastrointestinal disorders Nausea	7.1% 2/28 • Number of events 2 • 1 year
Gastrointestinal disorders Vomiting	10.7% 3/28 • Number of events 3 • 1 year
General disorders Pyrexia	10.7% 3/28 • Number of events 3 • 1 year
Injury, poisoning and procedural complications Contusion	7.1% 2/28 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Wound complication	7.1% 2/28 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Shunt stenosis	14.3% 4/28 • Number of events 5 • 1 year
Metabolism and nutrition disorders Diabetes mellitus	7.1% 2/28 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Back pain	7.1% 2/28 • Number of events 2 • 1 year

Additional Information

Director of Research

Edwards Lifesciences

Phone: 949-250-2500

Email: THV_CT.gov@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER