CoreValve® System Australia/New Zealand Clinical Study

NCT01015612 | Completed Results DMC

• 1 other identifier: CV-PAVR-R2007
• Study Type: interventional
• Target: 634
• Locations: 2 countries
• Sites: 10

Brief Summary

To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis; Aortic Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate

  Defined as a composite of all cause death, myocardial infarction(MI) (Q-wave \& non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)

  30 days

• Percentage of Participants With Overall Device Success

  * Vascular access, delivery and deployment of the device, and retrieval of the delivery system * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function) * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted * No occurrence of in-hospital MACCE

  24-48 hours after the procedure or before the discharge

• Cardiac-related Death

  Defined as all death resulting from a cardiac cause or complications of a cardiac procedure and / or death of an unknown cause; this category includes valve-related deaths and non-valve-related cardiac deaths (e.g. congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).

  30 days

Secondary Outcomes (4)

• All-Cause Mortality

  30 days

• Myocardial Infarction

  30 days

• Stroke

  30 days

• Re-intervention

  30 days

Study Arms (1)

Medtronic CoreValve® System Implantation

EXPERIMENTAL

Patients with symptomatic severe aortic stenosis who have an elevated surgical risk

Device: Medtronic CoreValve® System

Interventions

Medtronic CoreValve® System DEVICE

The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk

Medtronic CoreValve® System Implantation

Eligibility Criteria

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

You may qualify if:

• Documented severe aortic valve stenosis
• Access vessel diameter \>6 mm as defined pre procedure via angiographic measure
• Aortic valve annulus diameter ≥ 20 mm and \< 29 mm as defined pre procedure by echocardiographic measure
• Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
• Native aortic valve disease, defined as valve stenosis with an aortic valve area\<1cm2 (\<0.6cm2 /m2) as defined pre procedure by echocardiographic measure
• AND (Assessment of Surgical Risk)
• Age ≥ 80 years
• AND/OR
• Surgical risk calculated with logistic EuroSCORE ≥ 20%,
• AND/OR
• Age ≥ 65 years with one or two (but not more than 2) of the following criteria:
• Cirrhosis of the liver (Child class A or B)
• Pulmonary insufficiency : VMS \< 1 liter
• Previous cardiac surgery (CABG, valvular surgery)
• Porcelain aorta

You may not qualify if:

• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
• Any sepsis, including active endocarditis.
• Recent myocardial infarction (\<30 days)
• Any left ventricular or atrial thrombus as determined pre procedure by echocardiography
• Uncontrolled atrial fibrillation
• Mitral or tricuspid valvular insufficiency (\> grade II)
• Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
• Evolutive or recent CVA (cerebrovascular accident), (\<3 months)
• Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
• Symptomatic carotid or vertebral arteries narrowing (\> 70%) disease
• Abdominal or thoracic aortic aneurysm
• Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
• Evolutive disease with life expectancy less than one year
• Creatinine clearance \< 20 ml/min
• Active gastritis or known peptic ulcer disease

Sponsors & Collaborators

• Medtronic Cardiovascular: lead
• Medtronic Australasia: collaborator

Study Sites (10)

St. Vincents Sydney

Darlinghurst, New South Wales, Australia

Location

Prince Charles Hospital

Chermside, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Monash Hospital

Clayton, Victoria, Australia

Location

St. Vincent's Melbourne

Fitzroy, Victoria, Australia

Location

Epworth Hospital

Melbourne, Victoria, 3004, Australia

Location

Alfred Hospital

Melbourne, Victoria, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

Mercy Hospital

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

Related Publications (8)

• Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.

  PMID: 18848134 BACKGROUND

• Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006 Dec;82(6):2111-5. doi: 10.1016/j.athoracsur.2006.07.048.

  PMID: 17126120 BACKGROUND

• Sundt TM, Bailey MS, Moon MR, Mendeloff EN, Huddleston CB, Pasque MK, Barner HB, Gay WA Jr. Quality of life after aortic valve replacement at the age of >80 years. Circulation. 2000 Nov 7;102(19 Suppl 3):III70-4. doi: 10.1161/01.cir.102.suppl_3.iii-70.

  PMID: 11082365 BACKGROUND

• Kastrup J, Wennevold A, Thuesen L, Nielsen TT, Kassis E, Fritz-Hansen P, Thayssen P. Short- and long-term survival after aortic balloon valvuloplasty for calcified aortic stenosis in 137 elderly patients. Dan Med Bull. 1994 Jun;41(3):362-5.

  PMID: 7924464 BACKGROUND

• Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004 Feb 18;43(4):698-703. doi: 10.1016/j.jacc.2003.11.026.

  PMID: 14975485 BACKGROUND

• Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol. 2006 Mar 21;47(6):1214-23. doi: 10.1016/j.jacc.2006.01.049. Epub 2006 Feb 9.

  PMID: 16545654 BACKGROUND

• Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006 Oct 10;114(15):1616-24. doi: 10.1161/CIRCULATIONAHA.106.639450. Epub 2006 Oct 2.

  PMID: 17015786 BACKGROUND

• Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol. 2007 Jul 3;50(1):69-76. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.

  PMID: 17601548 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Deama Amr (PhD)
• Organization: Medtronic

deama.amr@medtronic.com

+61 2 9857 9157

Study Officials

• Ian T Meredith, MD

  Monash Heart Medical Center

  PRINCIPAL INVESTIGATOR

• Eric Vang

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: November 17, 2009
• First Posted: November 18, 2009
• Study Start: August 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2016
• Last Updated: November 12, 2019
• Results First Posted: October 19, 2018

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); AU (8)