100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
This study aims to examine the optimal anticoagulation/antiplatelet regimen in low risk patients undergoing TAVR. The prospective randomized controlled arm of this study will assess the utility of short-term oral anticoagulation with warfarin compared to antiplatelet therapy alone after TAVR in low risk patients to reduce the incidence of structural valve deterioration manifest as clinical events, increased aortic valve gradients or transvalvular regurgitation, or subclinical leaflet thrombosis. Low risk subjects with symptomatic severe aortic stenosis will be enrolled to undergo TAVR. Following TAVR, subjects will be randomized to receive warfarin plus low dose Aspirin or low dose Aspirin monotherapy for 30-45 days. Subjects with other indications for anticoagulation (e.g. AF, DVT or PE) will not be randomized and instead will be followed in a separate registry arm. Baseline demographic, clinical, non-invasive imaging (echocardiography and CT), TAVR procedural details, clinical follow up data will be prospectively collected for all subjects. Echocardiography and contrast-enhanced 4D cardiac CT will be performed in all subjects between 30-45 days after TAVR to evaluate for evidence of structural valve deterioration. This multicenter prospective randomized study will enroll 200 consecutive low risk subjects with symptomatic severe aortic stenosis into the treatment arms of the study. Up to 100 additional subjects with a pre-existing indication for anticoagulation (e.g. atrial fibrillation, deep venous thrombosis or pulmonary embolism) or who are not eligible for randomization after TAVR due to development of a new indication for anticoagulation will be enrolled into the registry arm of the study. Inclusion of this registry arm will ensure that the secondary objective pooled analysis of patient level data from this study and the Low Risk TAVR (LRT) study, truly represents an all-comers cohort of low risk patients undergoing TAVR, and does not exclude a significant subgroup.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Transcatheter Aortic Valve Replacement
Subjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR
Subjects randomized to this arm will receive aspirin only post TAVR
Foundation for Cardiovascular Medicine
San Diego, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Stony Brook Hospital
Stony Brook, New York, United States
All Cause Mortality
Time frame: 30 days
All Stroke
disabling and non-disabling, ischemic, hemorrhagic
Time frame: 30 days
Life-threatening and Major Bleeding
Time frame: 30 days
Major Vascular Complications
Time frame: 30 Days
Hospitalizations for valve-related symptoms or worsening congestive heart failure
Time frame: 30 days
Hypoattenuated leaflet thickening (HALT)
Time frame: 30 days
At least moderately restricted leaflet motion (RELM)
Time frame: 30 days
Hemodynamic dysfunction
(mean aortic valve gradient ≥20 mm Hg, AND/OR EOA ≤1.0 cm2 AND/OR DVI\<0. 35, AND/OR moderate or severe prosthetic valve regurgitation)
Time frame: 30 Days
VARC-2 device success:
* 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)
Time frame: 1 year
All-cause mortality
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. John Health System
Tulsa, Oklahoma, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Henrico Doctors' Hospital
Richmond, Virginia, United States
Time frame: 1 year
All stroke
(disabling and non-disabling, ischemic and hemorrhagic)
Time frame: 1 year
Life-threatening and major bleeding
Time frame: 1 year
Major vascular complications
Time frame: 1 year
Hospitalizations for valve-related symptoms or worsening congestive heart failure
Time frame: 1 year
Acute kidney injury
Time frame: 1 year
Pacemaker implantation
Time frame: 1 year
Endocarditis
Time frame: 1 year