Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

NCT01700439 | Completed Results DMC FDA Device

• 1 other identifier: 2011-02
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 29

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort

  Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]

  Events occurring ≥ 31 days and up through 8 years post-implant

Secondary Outcomes (14)

• Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success

  Day of procedure

• Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success

  Day of procedure through discharge or 10 days post index procedure, whichever comes first.

• Average Amount of Time Subject Spent on Cardiopulmonary Bypass

  Day of procedure

• Average Subject Time on Cardiopulmonary Cross Clamp

  Day of procedure

• Average Number of Days Subjects Were in the Intensive Care Unit (ICU)

  Day of procedure through discharge from the hospital

Other Outcomes (6)

• Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey

  Baseline and one year follow-up

• Subject's Average White Blood Cell Count Over Time

  Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

• Subject's Average Red Blood Cell Count Over Time

  Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

Study Arms (1)

EDWARDS INTUITY valve

EXPERIMENTAL

All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.

Device: EDWARDS INTUITY valve

Interventions

EDWARDS INTUITY valve DEVICE

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

EDWARDS INTUITY valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pure aortic insufficiency
• Requires emergency surgery
• Previous aortic valve replacement
• 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
• Requires multiple valve replacement/repair
• Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
• Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
• Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
• Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
• Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
• Hyperparathyroidism
• MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
• Presence of non-cardiac disease limiting life expectancy to less than 12 months
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Left ventricular ejection fraction ≤ 25%

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (29)

Keck Hospital of University of Southern California

Los Angeles, California, 90033, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

The University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

North Shore Long Island Jewish Health System

Manhasset, New York, 11030, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17010, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

St. Thomas Health

Nashville, Tennessee, 37205, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (2)

• 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.

  PMID: 27817951 RESULT

• 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.

  PMID: 29705366 RESULT

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: Jennifer Currin, Senior VP of Medical and Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Jennifer_Currin@edwards.com

949-250-2500

Study Officials

• Glenn Barnhart, MD

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

• Walter Randolph Chitwood, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: September 19, 2012
• First Posted: October 4, 2012
• Study Start: September 26, 2012
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: May 19, 2023
• Results First Posted: December 13, 2017

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)