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

Primary Purpose

Aortic Valve Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAVR Warfarin
SAVR Aspirin
TAVR Warfarin and clopidogrel
TAVR Aspirin and clopidogrel
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Valve Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

SAVR Warfarin Arm

TAVR Warfarin and Clopidogrel Arm

SAVR Aspirin Arm

TAVR Aspirin and Clopidogrel Arm

Arm Description

Warfarin arm-(target INR of 2-3)

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

Aspirin arm (81mg/day)

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 16, 2016
Last Updated
July 26, 2018
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02696226
Brief Title
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
Official Title
A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAVR Warfarin Arm
Arm Type
Experimental
Arm Description
Warfarin arm-(target INR of 2-3)
Arm Title
TAVR Warfarin and Clopidogrel Arm
Arm Type
Experimental
Arm Description
Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm
Arm Title
SAVR Aspirin Arm
Arm Type
Experimental
Arm Description
Aspirin arm (81mg/day)
Arm Title
TAVR Aspirin and Clopidogrel Arm
Arm Type
Experimental
Arm Description
Aspirin (81mg/day) and Clopidogrel (75mg/day) arm
Intervention Type
Drug
Intervention Name(s)
SAVR Warfarin
Other Intervention Name(s)
Coumadiin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SAVR Aspirin
Other Intervention Name(s)
Aspirin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TAVR Warfarin and clopidogrel
Other Intervention Name(s)
Coumadin, Plavix
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TAVR Aspirin and clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
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
Primary Outcome Measure Information:
Title
Leaflet Motion
Description
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).
Time Frame
4-6 weeks post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Johnston, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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