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

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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Aortic Stenosis
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation (TAVI)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written Informed Consent for participation prior to procedure.
2. Legal age in host country.
3. Aortic annulus 19-21mm diameter
4. 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)
5. NYHA Functional Classification of II or greater.
6. Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
7. Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving TAVI valve	Device: Transcatheter Aortic Valve Implantation (TAVI); Placement of the SJM TAVI aortic valve with a transfemoral delivery system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through 12 months post implantation

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Ganesh Manoharan, MD, Royal Victoria Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 1, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 7, 2011

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: aortic valve replacement; aortic stenosis; transcatheter aortic valve implantation; TAVI; aortic valve stenosis; TAVR; valvular heart disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 1103