Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

ConditionsTranscatheter Aortic Valve Replacement (TAVR)Aortic-Stenosis Aortic Insufficiency Degenerative Valve Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorInstitut für Pharmakologie und Präventive Medizin

About this trial

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years)

Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve

Patient is willing to attend the follow-up visits up to 10 years at the center

Disqualifiers

Lack of written informed consent

Emergency procedure

Pregnancy at time of TAVI

Freedom from mortality

Trial population

Adult patiets with severe aortic stenosis planned to undergo TAVR on their native valve with a SAPIEN 3 Ultra RESILIA Valve.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Transcatheter aortic valve (S3UR) replacement (TAVR)
Procedure/Surgery
Elective transfemoral TAVi procedure with S3UR valve.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: TAVI Patients1 intervention

Trial outcomes

Primary outcomes

Early Safety

Early safety acc. to VARC-3

Time frame

1-3 months

Device Success

Device Success acc. to VARC-3

Time frame

1-3 months

Bioprosthetic Valve Failure

Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operations/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))

Time frame

3-5 years

Bioprosthetic Valve Failure

Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operation/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))

Time frame

9-10 years

Secondary outcomes

Hemodynamic Valve Performance

* Prosthetic valve regurgitation including paravalvular regurgitation * Mean transvalvular gradient * Max transvalvular gradient * Effective orifice area

Time frame

All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)

Bioprosthetic Valve Failure

Bioprosthetic Valve Failure acc. to VARC-3

Time frame

All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)

Bioprosthetic Valve Dysfunction

BVD acc. to VARC-3

Time frame

All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

Patient reported outcomes

Patient reported outcomes using TASQ questionnaire and EQ-5D questionnaire

Time frame

1-3month, 1+3year Follow Up compared to BL

Other outcomes

Overall kidney function

Kidney function assessed through lab values: eGFR in ml/min/1,73m2; creatinine in mg/dl or micromol/l; albumin-to-creatinin-ratio in mg/g; serum calcium in mg/dl or millimol/l ; serum phosphate in mg/dl or millimol/l ; PTH intact in pmol/l, pg/ml or ng/l; Hb in g/l, g/dl, millimol/l

Time frame

All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

Overall Lipid Status

Lipid status assessed through lab values: total cholesterol in mg/dl, millimol/l or micromol/l; LDL in millimol/l or micromol/l; HDL millimol/l or micromol/l;Triglycerides in mg/dl, millimol/l or micromol/l; latest HbA1c in %; Lp(a) in mg/dl or nmol/l

Time frame

All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut für Pharmakologie und Präventive Medizin

Lead sponsor

Source ClinicalTrials.gov

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