Clinical trial NCT01015612: CoreValve® System Australia/New Zealand Clinical Study
Official title: CoreValve® System Australia/New Zealand Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Aortic Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Australasia
First posted: 2009-11-18
Enrollment: 634
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
timeFrame: 30 days
measure: Percentage of Participants With Overall Device Success
timeFrame: 24-48 hours after the procedure or before the discharge
measure: Cardiac-related Death
timeFrame: 30 days
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: 30 days
measure: Myocardial Infarction
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Re-intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincents Sydney
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Mercy Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Monash Heart Medical Center
name: Ian T Meredith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic
name: Eric Vang
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1016/j.athoracsur.2006.07.048.
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. doi: 10.1161/01.cir.102.suppl_3.iii-70.
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.
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. doi: 10.1016/j.jacc.2003.11.026.
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. doi: 10.1016/j.jacc.2006.01.049. Epub 2006 Feb 9.
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. doi: 10.1161/CIRCULATIONAHA.106.639450. Epub 2006 Oct 2.
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. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.