Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.

Study Overview
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Brief Summary
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This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.

Detailed Description
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This will be a pilot prospective randomized controlled trial.The study will enroll 50 adult patients scheduled to undergo SAVR and 50 adult patients scheduled to undergo TAVR. Subjects who satisfy Inclusion/Exclusion Criteria will be approached for informed consent. Those who give informed consent will be enrolled. After induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups. SAVR patients will get either Warfarin or aspirin TAVR patients will get either Warfarin or aspirin. Patients will be seen at 4-6 weeks postoperatively for Transthoracic ECHO (TTE), 4 dimensional (4D), Multidetector computed tomography (MDCT) scan and review of medical history. Phone follow up at 6,9 and 12 months post-operatively. Data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance

Official Title
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A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial

Conditions
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Aortic Valve Disorder

Intervention / Treatment
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* Drug: SAVR Warfarin
* Drug: SAVR Aspirin
* Drug: TAVR Warfarin and clopidogrel
* Drug: TAVR Aspirin and clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for SAVR or TAVR Age > 18 years Able and willing to give informed consent Able and willing to return for follow up Exclusion Criteria: Contraindications to warfarin, Plavix or aspirin Pre-existing medical indication for warfarin, Plavix or aspirin History of previous cardiac surgery History of previous coronary artery stenting Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR < 60 ml/min).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAVR Warfarin Arm<br>Warfarin arm-(target INR of 2-3) | Drug: SAVR Warfarin<br>* Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely<br>* Other names: Coumadiin;|
| Experimental: TAVR Warfarin and Clopidogrel Arm<br>Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm | Drug: TAVR Warfarin and clopidogrel<br>* Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely<br>* Other names: Plavix;|
| Experimental: SAVR Aspirin Arm<br>Aspirin arm (81mg/day) | Drug: SAVR Aspirin<br>* Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.<br>* Other names: Aspirin;|
| Experimental: TAVR Aspirin and Clopidogrel Arm<br>Aspirin (81mg/day) and Clopidogrel (75mg/day) arm | Drug: TAVR Aspirin and clopidogrel<br>* Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leaflet Motion | Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (>70% reduction), or immobile (lack of motion of at least one valve leaflet). | 4-6 weeks post procedure |