Clinical trial NCT01700439: Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
Official title: Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Keywords: Aortic valve
Heart valve
Tissue valve
Bioprosthesis
Valve disorder
Valve disease
Cardiac surgery
Less invasive cardiac surgery
Aortic valve stenosis
Aortic valve regurgitation
Bovine pericardium
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Detailed description: This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria - Subjects will be required to meet all inclusion criteria:

  1. Male or female, age 18 years or older
  2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation
  3. Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
  4. Provide written informed consent
  5. Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

Exclusion Criteria:

- Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:

1. Pure aortic insufficiency
2. Requires emergency surgery
3. Previous aortic valve replacement
4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
5. Requires multiple valve replacement/repair
6. Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
7. Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
11. Hyperparathyroidism
12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
13. Presence of non-cardiac disease limiting life expectancy to less than 12 months
14. Hypertrophic obstructive cardiomyopathy (HOCM)
15. Left ventricular ejection fraction ≤ 25%
16. Documented history of substance (drug or alcohol) abuse within the last 5 years
17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
18. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
19. Pregnancy, lactation, or planning to become pregnant;
20. Currently incarcerated or unable to give voluntary informed consent
21. Leucopenia (WBC \< 3.5x 103/µL), or acute anemia (Hgb \< 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count \< 50x 103/µL), or history of bleeding diathesis or coagulopathy
22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
23. Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial

    * Intra-operative Exclusion Criteria
24. Anatomic variances which contraindicate implant of the trial valve, such as:

    1. anomalous coronary arteries
    2. annular deformation or extensive calcification of the annulus or aortic root which cannot be removed
    3. significant calcium on the anterior mitral leaflet
    4. pronounced septal calcification
    5. position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow
25. Available devices are not suitably sized for the subject's annulus

Primary outcomes:
measure: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
timeFrame: Events occurring ≥ 31 days and up through 8 years post-implant
Secondary outcomes:
measure: Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
timeFrame: Day of procedure
measure: Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
timeFrame: Day of procedure through discharge or 10 days post index procedure, whichever comes first.
measure: Average Amount of Time Subject Spent on Cardiopulmonary Bypass
timeFrame: Day of procedure
measure: Average Subject Time on Cardiopulmonary Cross Clamp
timeFrame: Day of procedure
measure: Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
timeFrame: Day of procedure through discharge from the hospital
measure: Subject's New York Heart Association (NYHA) Classification Over Time
timeFrame: Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years
measure: Subject's Average Mean Gradient Measurements Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
measure: Subject's Average Peak Gradient Measurements Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
measure: Subject's Effective Orifice Area (EOA) Measurement Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Performance Index Measurement Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Cardiac Output Measurement at Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Cardiac Index Measurement Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Other outcomes:
measure: Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
timeFrame: Baseline and one year follow-up
measure: Subject's Average White Blood Cell Count Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Average Red Blood Cell Count Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Average Hematocrit Percentage Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Average Hemoglobin Percentage Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
measure: Subject's Average Plasma Free Hemoglobin Over Time
timeFrame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: The University of Michigan Medical School
state: Michigan
city: Saint Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Manhasset
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Health
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Swedish Medical Center
name: Glenn Barnhart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Carolina University
name: Walter Randolph Chitwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.
citation: Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.