Health TrialsbyHealthPanel

FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis

ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorValve Medical

About this trial

The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.

This is a prospective, open label, multicentre, single arm, first in human clinical study.

Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Patient understands the implications of participating in the study and provides informed consent

Patient is willing to comply with specified follow-up evaluation

Severe aortic stenosis as per ACC/AHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6cm2/m2)* AND PV ≥ 4 m/sec or mean gradient ≥ 40 mmHg)** as determined by TTE/CT-TAVI

Disqualifiers

Patient not suitable for surgical bailout

Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.

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

Active or recent (within 6 months) endocarditis.

Trial design

Design model

Single group

Treatments tested in this trial

  • GEMINUS Transcatheter Aortic Valve Implantation system

    Device

    Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: GEMINUS Transcatheter Aortic Valve Implantation systemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical success (at exit from procedure room)

Technical success (at exit from procedure room) composite endpoint: Freedom from mortality, Successful access, delivery of the device, and retrieval of the delivery System, Correct positioning of a single prosthetic heart valve into the proper anatomical location, Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

Time frame
immediately after procedure

Secondary outcomes

1

Device success composite endpoint

Device success composite endpoint: Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)

Time frame
30 days
2

Early safety composite endpoint (VARC 3)

Early safety composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from ≥ VARC-3 type 2 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device

Time frame
30 days
3

Early safety composite endpoint (Modified VARC)

Early safety composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from ≥ Modified VARC type 3 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device

Time frame
30 days
4

Clinical efficacy composite endpoint

Clinical efficacy composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from hospitalization for procedure- or valve-related causes; Freedom from KCCQ Overall Summary Score \<45 or decline from baseline of \>10 point (i.e. Unfavourable Outcome)

Time frame
1, 2, 3, 4, 5 years

Other outcomes

Sponsors and contacts

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

Valve Medical

Lead sponsor

Source ClinicalTrials.gov
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