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Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT02628899
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low‐risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: Transfemoral TAVR Device: SAVR Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Prospective TAVR Arm
200 patients prospectively undergoing transfemoral TAVR
Device: Transfemoral TAVR
Other Name: Transcatheter aortic valve replacement

Historical SAVR Controls
Historical controls will be selected from among patients at the same site who have undergone isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched to SAVR patients using STS database variables to perform propensity matching, including (but not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size.
Device: SAVR
Other Name: Surgical Aortic Valve Replacement

Low-Risk TAVR with Bicuspid Aortic Valve
The third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients with bicuspid aortic valve. The results from the registry arm will be analyzed independently.
Device: Transfemoral TAVR
Other Name: Transcatheter aortic valve replacement




Primary Outcome Measures :
  1. All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR [ Time Frame: 30 days following transfemoral TAVR vs. bioprosthetic SAVR ]
    All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR

  2. Composite of major adverse events at 30 days [ Time Frame: 30 days ]

    Composite of major adverse events at 30 days

    1. all‐cause mortality
    2. stroke
    3. spontaneous myocardial infarction (MI)
    4. reintervention: defined as any cardiac surgery or percutaneous reintervention that repairs, alters, or replaces a previously implanted aortic valve
    5. VARC life‐threatening bleeding
    6. Increase in serum creatinine to ≥300% (>3x increase compared to baseline) OR serum creatinine ≥4.0 mg/dL with an acute increase ≥0.5 mg/dL OR new requirement for dialysis
    7. coronary artery obstruction requiring percutaneous or surgical intervention
    8. VARC major vascular complication
    9. cardiac tamponade
    10. cardiac perforation
    11. pericarditis
    12. mediastinitis
    13. hemolysis
    14. infective endocarditis
    15. moderate or severe aortic insufficiency
    16. significant aortic stenosis
    17. permanent pacemaker implantation

  3. All Cause Mortality [ Time Frame: 30 days ]
  4. All Stroke (disabling and non-disabling, ischemic and hemorrhagic [ Time Frame: 30 Days ]
  5. Life Threatening and Major Bleeding [ Time Frame: 30 days ]
  6. Major Vascular Complications [ Time Frame: 30 days ]
  7. Hospitalizations for valve-related symptoms or worsening congestive heart failure [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. composite of all‐cause mortality, stroke, spontaneous MI, re-intervention [ Time Frame: 30 days, 6 months, 12 months, and 2,3,4 and 5 years ]

    composite of:

    1. all‐cause mortality
    2. stroke
    3. spontaneous MI
    4. re-intervention 2. The occurrence of the individual components of MACCE at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years. 3. The composite of major adverse device events post‐procedure, and at 6 months, 1 year, and 2, 3, 4, 5 years 4. VARC major vascular complications, at 30 days and 1 year 5. VARC life‐threatening or disabling bleeding, at 30 days and 1 year 6. Assessment for subclinical leaflet thrombosis with multislice computed tomography, or transesophageal echocardiography if GFR <50 mL/min/m2, at 1 to 2 months.

  2. VARC - 2 Device Success [ Time Frame: 30 days ]
    Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s, AND no moderate or severe prosthetic valve regurgitation)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe, degenerative AS, defined as:

    1. mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
    2. calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2
  2. Symptomatic AS, defined as a history of at least one of the following:

    1. dyspnea that qualifies at New York Heart Association (NYHA) class II or greater
    2. angina pectoris
    3. cardiac syncope
  3. The Heart Team, including at least one cardiothoracic surgeon and one interventional cardiologist, deem the patient to be reasonable for transfemoral TAVR with a commercially available bioprosthetic valve
  4. The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered.
  5. The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon multislice CT measurements
  6. Procedure status is elective
  7. Expected survival is at least 24 months

    For the bicuspid cohort only:

  8. Aortic Stenosis of a bicuspid aortic valve

Exclusion Criteria:

  1. Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention
  2. Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve)
  3. Aortic stenosis secondary to a bicuspid aortic valve (except for the bicuspid valve cohort)
  4. Prior bioprosthetic surgical aortic valve replacement
  5. Mechanical heart valve in another position
  6. End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance <20 cc/min
  7. Left ventricular ejection fraction <20%
  8. Recent (<6 months) history of stroke or transient ischemic attack
  9. Symptomatic carotid or vertebral artery disease, or recent (<6 weeks) surgical or endovascular treatment of carotid stenosis
  10. Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure, including recent or ongoing bleeding, or HASBLED score >3
  11. Severe coronary artery disease that is unrevascularized
  12. Recent (<30 days) acute myocardial infarction
  13. Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by supplemental imaging studies); this would include inadequate size of iliofemoral access vessels or an aortic annulus size that is not accommodated by the commercially available valves
  14. Any comorbidity not captured by the STS score that would make SAVR high risk, as determined by a cardiothoracic surgeon who is a member of the heart team; this includes:

    1. porcelain or severely atherosclerotic aorta
    2. frailty
    3. hostile chest
    4. IMA or other conduit either crosses midline of sternum or is adherent to sternum
    5. severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure)
    6. severe right ventricular dysfunction
  15. Ongoing sepsis or infective endocarditis
  16. Recent (<30 days) or ongoing bleeding that would preclude treatment with anticoagulant or antiplatelet therapy, including recent gastrointestinal bleeding
  17. Uncontrolled atrial fibrillation (resting heart rate >120 beats per minute)
  18. Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc
  19. Liver failure with Childs class C or D
  20. Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest
  21. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
  22. Known allergy to warfarin or aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628899


Locations
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United States, California
Sutter Health System Recruiting
Sacramento, California, United States, 95816
Contact: Wynell Richardson    916-887-4172    MelvinW@sutterhealth.org   
Principal Investigator: David Roberts, MD         
Sub-Investigator: Michael Ingram, MD         
Foundation for Cardiovascular Medicine Recruiting
San Diego, California, United States, 92121
Contact: Diane Wilkerson, RN    858-625-4488    dwilkerson@fcvmed.org   
Principal Investigator: Maurice Buchbinder, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Roshni S Bastian, MPH    202-877-7752    roshni.s.bastian@medstar.net   
Principal Investigator: Ron Waksman, MD         
United States, Georgia
WellStar Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30060
Contact: Barbara Ann Foster, RN    770-793-5974    Barbara.A.Foster@wellstar.org   
Principal Investigator: Amar Patel, MD         
Sub-Investigator: William Cooper, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Susan Bosworth-Farrell, RN    207-662-2687    SABosworth@mmc.org   
Contact: Joanne Burgess, RN    207-662-6317    BURGEJS@mmc.org   
Principal Investigator: David Butzel, MD         
United States, New Jersey
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Kimberly Michel, RN    201-447-8453    kmichel@valleyhealth.com   
Principal Investigator: John A Goncalves, MD         
Sub-Investigator: Sean R Wilson, MD         
Sub-Investigator: Thomas P Cocke, MD         
United States, New York
Stony Brook Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Ruth Stein, RN    631-444-3309    ruth.stein@stonybrookmedicine.edu   
Contact: Samantha Maier, SN    631-444-3309    Samantha.Maier@stonybrook.edu   
Principal Investigator: Luis Gruberg, MD         
Principal Investigator: Thomas Bilfinger, MD         
Sub-Investigator: Giridhar Korlipara, MD         
Sub-Investigator: Puja Parikh, MD         
Sub-Investigator: Henry Tannous, MD         
Sub-Investigator: Jonathan Weinstein, MD         
United States, Oklahoma
St. John Health System Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Grace Aquino, RN    918-744-3426    Grace.Aquino@ascension.org   
Contact: Christopher O Fergus, RN    918-744-3426    Christopher.Fergus@ascension.org   
Principal Investigator: Nicholas Hanna, MD         
Sub-Investigator: Robert Garrett, MD         
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Elizabeth Coccio    401-793-5554      
Principal Investigator: Paul Gordon, MD         
United States, Virginia
Henrico Doctors' Hospital Recruiting
Richmond, Virginia, United States, 23229
Contact: Kyle Narron    804-287-4312    Kyle.Narron@SarahCannon.com   
Principal Investigator: Robert Levitt, MD         
Principal Investigator: Chiown Hahn, MD         
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Melissa Sears, RN    804-828-1601    melissa.sears@vcuhealth.org   
Principal Investigator: Zachary Gertz, MD         
Sub-Investigator: Mohammed Quader, MD         
Sponsors and Collaborators
Medstar Health Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02628899     History of Changes
Other Study ID Numbers: Low Risk TAVR
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction