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

NCT01487330 | Completed

• 1 other identifier: 1103
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Aortic Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assessment of Technical Feasibility and Device Deployment Characteristics

  Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by: 1. The ability for the valve to be deployed at the desired location 2. The ability to complete the full procedure 3. Quantification of the time from delivery system entry to a fully deployed and functional valve

  At time of procedure

Secondary Outcomes (1)

• Quantification of SAEs Reported (Device Related or Procedure Related)

  Through 12 months post implantation

Study Arms (1)

Subjects receiving TAVI valve

EXPERIMENTAL

Device: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

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

Subjects receiving TAVI valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Royal Victoria Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Ganesh Manoharan, MD

  Royal Victoria Hospital, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: December 7, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: September 1, 2012
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

GB (1)