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

Not Applicable

Terminated

• Conditions: Aortic Valve Disorder
• Interventions: Drug: TAVR Aspirin and clopidogrel; Drug: SAVR Warfarin; Drug: TAVR Warfarin and clopidogrel; Drug: SAVR Aspirin

• Registration Number: NCT02696226
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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.

1. SAVR patients will get either Warfarin or aspirin

2. 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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Primary Completion: 2017-07-28
• Study Completion: 2017-07-28
• Results First Submitted: 2017-09-11
• Results First Submitted QC: 2017-10-11
• Results First Posted: 2017-11-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAVR Aspirin and Clopidogrel Arm	TAVR Aspirin and clopidogrel	Aspirin (81mg/day) and Clopidogrel (75mg/day) arm
SAVR Warfarin Arm	SAVR Warfarin	Warfarin arm-(target INR of 2-3)
TAVR Warfarin and Clopidogrel Arm	TAVR Warfarin and clopidogrel	Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm
SAVR Aspirin Arm	SAVR Aspirin	Aspirin arm (81mg/day)

Primary Outcome Measures

Name	Time	Method
Leaflet Motion	4-6 weeks post procedure	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).

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States