Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02696226|
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 2, 2016
Results First Posted : November 8, 2017
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Disorder||Drug: SAVR Warfarin Drug: SAVR Aspirin Drug: TAVR Warfarin and clopidogrel Drug: TAVR Aspirin and clopidogrel||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||July 28, 2017|
|Actual Study Completion Date :||July 28, 2017|
Experimental: SAVR Warfarin Arm
Warfarin arm-(target INR of 2-3)
Drug: SAVR Warfarin
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
Other Name: Coumadiin
Experimental: TAVR Warfarin and Clopidogrel Arm
Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm
Drug: TAVR Warfarin and clopidogrel
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
Experimental: SAVR Aspirin Arm
Aspirin arm (81mg/day)
Drug: SAVR Aspirin
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.
Other Name: Aspirin
Experimental: TAVR Aspirin and Clopidogrel Arm
Aspirin (81mg/day) and Clopidogrel (75mg/day) arm
Drug: TAVR Aspirin and clopidogrel
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
Other Name: Plavix
- Leaflet Motion [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696226
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Douglas Johnston, M.D.||The Cleveland Clinic|