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First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System (SJM TAVI FIH)

Primary Purpose

Symptomatic Aortic Stenosis

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Transcatheter Aortic Valve Implantation (TAVI)

About this trial

This is an interventional treatment trial for Symptomatic Aortic Stenosis focused on measuring aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI, TAVR

Eligibility Criteria

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

Inclusion Criteria:

Written Informed Consent for participation prior to procedure.
Legal age in host country.
Aortic annulus 19-21mm diameter
Senile degenerative aortic stenosis with derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2)
NYHA Functional Classification of II or greater.
Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.

Exclusion Criteria:

History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
Carotid artery disease requiring intervention.
Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
Aortic root angulation >70 degrees (horizontal aorta).
Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%.
Untreated coronary artery disease (CAD) requiring revascularization.
Severe basal septal hypertrophy.
Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation.
Evidence of intracardiac mass, thrombus, or vegetation.
Hemodynamic instability
Significant pulmonary disease.
Nonreactive pulmonary hypertension.
Chronic steroid use.
Hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis.
Morbid obesity defined as BMI ≥ 35.
Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass.
Ongoing infection or sepsis.
Blood dyscrasias
Significant aortic disease.
Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.

Sites / Locations

Royal Victoria Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects receiving TAVI valve

Arm Description

Outcomes

Primary Outcome Measures

Assessment of Technical Feasibility and Device Deployment Characteristics

Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by: The ability for the valve to be deployed at the desired location The ability to complete the full procedure Quantification of the time from delivery system entry to a fully deployed and functional valve

Secondary Outcome Measures

Quantification of SAEs Reported (Device Related or Procedure Related)

Evaluate the safety of the 23mm SJM Transcatheter Aortic Heart Valve and transfemoral delivery system by: Summarizing the SAEs observed at procedure that are device or procedure related Summarizing the SAEs observed during the study

Full Information

NCT ID

NCT01487330

First Posted

August 1, 2011

Last Updated

February 1, 2019

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01487330

Brief Title

First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System

Acronym

SJM TAVI FIH

Official Title

First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS). This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.

Detailed Description

Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

6. Conditions and Keywords

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

Symptomatic Aortic Stenosis

Keywords

aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI, TAVR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects receiving TAVI valve

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Description

Placement of the SJM TAVI aortic valve with a transfemoral delivery system.

Primary Outcome Measure Information:

Title

Assessment of Technical Feasibility and Device Deployment Characteristics

Description

Time Frame

At time of procedure

Secondary Outcome Measure Information:

Title

Quantification of SAEs Reported (Device Related or Procedure Related)

Description

Time Frame

Through 12 months post implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written Informed Consent for participation prior to procedure. Legal age in host country. Aortic annulus 19-21mm diameter Senile degenerative aortic stenosis with derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2) NYHA Functional Classification of II or greater. Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days. Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system. Exclusion Criteria: History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure. Carotid artery disease requiring intervention. Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure. Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis. Aortic root angulation >70 degrees (horizontal aorta). Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%. Untreated coronary artery disease (CAD) requiring revascularization. Severe basal septal hypertrophy. Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis. Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation. Evidence of intracardiac mass, thrombus, or vegetation. Hemodynamic instability Significant pulmonary disease. Nonreactive pulmonary hypertension. Chronic steroid use. Hypersensitivity or contraindication to anticoagulant or antiplatelet medication. Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis. Morbid obesity defined as BMI ≥ 35. Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass. Ongoing infection or sepsis. Blood dyscrasias Significant aortic disease. Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries. Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ganesh Manoharan, MD

Organizational Affiliation

Royal Victoria Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Victoria Hospital

City

Belfast

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System

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