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

NeuroTherapia, Inc.

Status: Terminated

Conditions: Aortic Valve Disorder

Treatments: Drug: SAVR Warfarin; Drug: TAVR Aspirin and clopidogrel; Drug: TAVR Warfarin and clopidogrel; Drug: SAVR Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02696226

16-084

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 4 patient groups

SAVR Warfarin Arm

Experimental group

Description:

Warfarin arm-(target INR of 2-3)

Treatment:

Drug: SAVR Warfarin

TAVR Warfarin and Clopidogrel Arm

Experimental group

Description:

Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm

Treatment:

Drug: TAVR Warfarin and clopidogrel

SAVR Aspirin Arm

Experimental group

Description:

Aspirin arm (81mg/day)

Treatment:

Drug: SAVR Aspirin

TAVR Aspirin and Clopidogrel Arm

Experimental group

Description:

Aspirin (81mg/day) and Clopidogrel (75mg/day) arm

Treatment:

Drug: TAVR Aspirin and clopidogrel