CoreValve® System Australia/New Zealand Clinical Study

Aortic Valve Stenosis Clinical Trial

Official title:

CoreValve® System Australia/New Zealand Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015612
• Other study ID #: CV-PAVR-R2007
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: September 2016

Study information

• Verified date: October 2019
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: September 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria

1. Documented severe aortic valve stenosis

2. Access vessel diameter >6 mm as defined pre procedure via angiographic measure

3. Aortic valve annulus diameter = 20 mm and < 29 mm as defined pre procedure by echocardiographic measure

4. Ascending aorta diameter = 43 mm at the sino-tubular junction

5. 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

• Pulmonary hypertension > 60 mmHg and high probability of cardiac surgery for other than valve replacement

• Recurrent pulmonary embolus

• Right ventricular insufficiency

• Thoracic burning sequelae contraindicating open chest surgery

• History of mediastinum radiotherapy

• Severe connective tissue disease resulting in a contraindication to surgery

• Cachexia (clinical impression)

6. Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit

Exclusion Criteria:

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

2. Any sepsis, including active endocarditis.

3. Recent myocardial infarction (<30 days)

4. Any left ventricular or atrial thrombus as determined pre procedure 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 CVA (cerebrovascular accident), (<3 months)

9. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve

10. Symptomatic carotid or vertebral arteries narrowing (> 70%) disease

11. Abdominal or thoracic aortic aneurysm

12. Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion

13. Evolutive disease with life expectancy less than one year

14. Creatinine clearance < 20 ml/min

15. Active gastritis or known peptic ulcer disease

16. Pregnancy

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Medtronic CoreValve® System
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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	Monash Hospital	Clayton	Victoria
Australia	St. Vincents Sydney	Darlinghurst	New South Wales
Australia	St. Vincent's Melbourne	Fitzroy	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Epworth Hospital	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
New Zealand	Mercy Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Medtronic Australasia

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & 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. — View Citation

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. Epub 2006 Feb 9. — View Citation

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. — View Citation

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. Epub 2006 Oct 2. — View Citation

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. Epub 2007 Jun 6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	All-Cause Mortality	is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.	30 days
Secondary	Myocardial Infarction	Included Q-wave and non-Q-wave.	30 days
Secondary	Stroke	Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.	30 days
Secondary	Re-intervention	Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.	30 days