ADVANCE Direct Aortic Study

Aortic Stenosis Clinical Trial

Official title:

CoreValve® ADVANCE Direct Aortic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676727
• Other study ID #: Advance-DA
• Status: Completed
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2018
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

Description:

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Severe symptomatic aortic valve stenosis requiring treatment

2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use

3. 21 years of age or older

4. Patient is willing and able to comply with all protocol-specified follow-up evaluations

5. The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")

6. Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated

2. Sepsis, including active endocarditis

3. Recent myocardial infarction (<30 days)

4. Left ventricular or atrial thrombus by echocardiography

5. Uncontrolled atrial fibrillation

6. Mitral or tricuspid valvular insufficiency (>grade II)

7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)

8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)

9. Patients with:

1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or

2. Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or

3. Thoracic aortic aneurysm in the path of delivery system

10. Bleeding diathesis or coagulopathy

11. Patient refuses blood transfusion

12. Estimated life expectancy of less than 12 months unless TAVI is performed

13. Creatine clearance <20 mL/min

14. Active gastritis or peptic ulcer disease

15. Pregnancy or intent to become pregnant during study follow up

16. Patient is participating in another trial that may influence the results of this study

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Device:
• CoreValve aortic valve
Implantation of CoreValve aortic valve via direct aortic approach

Locations

Country	Name	City	State
Czechia	Nemocnice Podlesi Trinec	Trinec
France	Hopital de Rangueil	Toulouse
Germany	Universitätsklinikum Halle (Saale)	Halle (Saale)
Italy	Azienda spedaliera Spedali Civili Di Brescia	Brescia
Italy	Azienda spedaliera Niguarda Ca' Granda Milano	Milano
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Medisch centrum Leeuwarden	Leeuwarden
United Kingdom	Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital	Brighton
United Kingdom	Royal Brompton & Harefield NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality	Kaplan-Meier estimate of 30-day all-cause mortality.	30 days post-implant
Secondary	Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	The combined safety endpoint is defined as a composite of: All-cause mortality; All stroke; Life-threatening bleeding; Acute kidney injury-Stage 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR); High degree AV block requiring permanent pacemaker implantation	1, 6 and 12 months