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

Primary Purpose

Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
GEMINUS Transcatheter Aortic Valve Implantation system
Sponsored by
Valve Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 *May be larger with mixed AS/AR **For low flow low gradient AS or paradoxical low flow severe AS must meet ACC/AHA guidelines (table 13 stages of AS in the guideline) Cardiac Symptoms: ≥ NYHA Class II Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old. Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI Anatomically suitable for implantation of the GEMINUS device Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter > 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system. Patients assessed by the heart team to be at high risk for access site related bleeding/vascular complications due to the caliber/ calcification/ atherosclerosis of the iliofemoral vessels. Exclusion Criteria: 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. Active systemic infections. Recent MI (≤ 1 month). Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure. Prosthetic heart valve in any position. Severe (> 3+) mitral, tricuspid or pulmonic regurgitation. Blood dyscrasias as defined: leukopenia (WBC<3000/mm3), acute anemia (Hb <8mg%), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy. Untreated clinically significant coronary artery disease requiring revascularization. Hemodynamic instability requiring inotropic support or mechanical support devices. Hypertrophic cardiomyopathy with or without obstruction (HCM). Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Active peptic ulcer or upper GI bleeding within the prior 3 months. Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated). Recent (<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA). Renal insufficiency (eGFR<30 mL/min) and/or end stage renal disease requiring chronic dialysis. Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter > 5cm), marked tortuosity, or severe aortic arch atheroma. Life expectancy < 12 months due to non-cardiac co-morbid conditions. Currently participating in an investigational drug or another device study that has not reached its primary endpoint

Sites / Locations

  • Rabin Medical CenterRecruiting
  • Tel Aviv Sourasly Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GEMINUS Transcatheter Aortic Valve Implantation system

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
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)
All-cause mortality
All-cause mortality
Disabling stroke
Disabling stroke
Any stroke
Any stroke
Peri-procedural MI (per ARC-2)
Peri-procedural MI (per ARC-2).
Repeat hospitalization for procedure or valve related cause
Repeat hospitalization for procedure or valve related cause
Repeat aortic valve intervention
Repeat aortic valve intervention
AKI (Stage 3 or 4)
AKI (Stage 3 or 4)
Bleeding ≥ VARC-3 type 2
Bleeding ≥ VARC-3 type 2
Bleeding ≥ Modified VARC type 3
Bleeding ≥ Modified VARC type 3
KCCQ
KCCQ
Hemodynamic valve performance: Mean pressure gradient
Hemodynamic valve performance: Mean pressure gradient
Hemodynamic valve performance: peak velocity
Hemodynamic valve performance: peak velocity
Hemodynamic valve performance: aortic valve area
Hemodynamic valve performance: aortic valve area
Hemodynamic valve performance: aortic regurgitation
Hemodynamic valve performance: aortic regurgitation
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities

Full Information

First Posted
May 30, 2023
Last Updated
June 8, 2023
Sponsor
Valve Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05909748
Brief Title
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
Official Title
First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
April 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valve Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GEMINUS Transcatheter Aortic Valve Implantation system
Arm Type
Experimental
Arm Description
Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation
Intervention Type
Device
Intervention Name(s)
GEMINUS Transcatheter Aortic Valve Implantation system
Other Intervention Name(s)
GEMINUS TAVI system
Intervention Description
Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system
Primary Outcome Measure Information:
Title
Technical success (at exit from procedure room)
Description
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 Outcome Measure Information:
Title
Device success composite endpoint
Description
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
Title
Early safety composite endpoint (VARC 3)
Description
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
Title
Early safety composite endpoint (Modified VARC)
Description
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
Title
Clinical efficacy composite endpoint
Description
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
Title
All-cause mortality
Description
All-cause mortality
Time Frame
30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Disabling stroke
Description
Disabling stroke
Time Frame
6 months, 2, 3, 4, 5 years
Title
Any stroke
Description
Any stroke
Time Frame
30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Peri-procedural MI (per ARC-2)
Description
Peri-procedural MI (per ARC-2).
Time Frame
within 2 days after procedure
Title
Repeat hospitalization for procedure or valve related cause
Description
Repeat hospitalization for procedure or valve related cause
Time Frame
30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Repeat aortic valve intervention
Description
Repeat aortic valve intervention
Time Frame
30 days, 6 months, 1, 2, 3, 4, 5 years
Title
AKI (Stage 3 or 4)
Description
AKI (Stage 3 or 4)
Time Frame
30 days
Title
Bleeding ≥ VARC-3 type 2
Description
Bleeding ≥ VARC-3 type 2
Time Frame
30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Bleeding ≥ Modified VARC type 3
Description
Bleeding ≥ Modified VARC type 3
Time Frame
30 days, 6 months, 1, 2, 3, 4, 5 years
Title
KCCQ
Description
KCCQ
Time Frame
6 months, 1 year
Title
Hemodynamic valve performance: Mean pressure gradient
Description
Hemodynamic valve performance: Mean pressure gradient
Time Frame
pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Hemodynamic valve performance: peak velocity
Description
Hemodynamic valve performance: peak velocity
Time Frame
pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Hemodynamic valve performance: aortic valve area
Description
Hemodynamic valve performance: aortic valve area
Time Frame
pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Hemodynamic valve performance: aortic regurgitation
Description
Hemodynamic valve performance: aortic regurgitation
Time Frame
pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Title
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
Description
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 *May be larger with mixed AS/AR **For low flow low gradient AS or paradoxical low flow severe AS must meet ACC/AHA guidelines (table 13 stages of AS in the guideline) Cardiac Symptoms: ≥ NYHA Class II Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old. Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI Anatomically suitable for implantation of the GEMINUS device Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter > 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system. Patients assessed by the heart team to be at high risk for access site related bleeding/vascular complications due to the caliber/ calcification/ atherosclerosis of the iliofemoral vessels. Exclusion Criteria: 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. Active systemic infections. Recent MI (≤ 1 month). Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure. Prosthetic heart valve in any position. Severe (> 3+) mitral, tricuspid or pulmonic regurgitation. Blood dyscrasias as defined: leukopenia (WBC<3000/mm3), acute anemia (Hb <8mg%), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy. Untreated clinically significant coronary artery disease requiring revascularization. Hemodynamic instability requiring inotropic support or mechanical support devices. Hypertrophic cardiomyopathy with or without obstruction (HCM). Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Active peptic ulcer or upper GI bleeding within the prior 3 months. Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated). Recent (<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA). Renal insufficiency (eGFR<30 mL/min) and/or end stage renal disease requiring chronic dialysis. Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter > 5cm), marked tortuosity, or severe aortic arch atheroma. Life expectancy < 12 months due to non-cardiac co-morbid conditions. Currently participating in an investigational drug or another device study that has not reached its primary endpoint
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Koltun Reuven
Phone
972-542666688
Email
brendak@medinol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Kornowski, Prof.
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Kornowski, Prof.
First Name & Middle Initial & Last Name & Degree
Ran Kornowski
Facility Name
Tel Aviv Sourasly Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maayan Konigstein, Prof.
First Name & Middle Initial & Last Name & Degree
Maayan Konigstein, Prof

12. IPD Sharing Statement

Learn more about this trial

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

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