TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
ConditionBicuspid Aortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCedars-Sinai Medical Center
About this trial
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR).
TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease..
SAVR is involving the open chest surgery to replace the aortic valve.
The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA.
Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure.
Consented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms.
The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
50 years of age or older at time of consent
Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)
Gated contrast CT available and suitable for core laboratory analysis;
BAV anatomy confirmed by CT core laboratory analysis
Disqualifiers
Recent cardiovascular intervention within 30 days prior to randomization.
Presence of an existing TAVR or SAVR device
Pregnancy or lactation
Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review
Trial design
Design model
Parallel
Treatments tested in this trial
Transcatheter Aortic Valve Replacement
Procedure/SurgeryThis is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
the open chest surgery to replace the aortic valve
Procedure/SurgeryThis is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Transcatheter Aortic Valve Replacement TAVROther 1 intervention
Group B: Surgical Aortic Valve Replacement SAVRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV
A hierarchical composite (assessed by Win ratio at latest available follow-up) of: 1. death, 2. disabling stroke, 3. non-disabling stroke, 4. valve reintervention, 5. rehospitalization†, 6. unfavorable KCCQ (VARC-3\*)
Time frame
2 years post end of enrollmentSecondary outcomes
1
Time-averaged KCCQ
time-weighted mean of KCCQ overall summary score across at follow-up timepoints
Time frame
3 years post end of enrollment2
KCCQ status (serial)
overall summary score at discharge and specified follow-up visits
Time frame
at 2 years post end of enrollment3
SF-12 questionnaire
physical and mental component summary scores at prespecified visits.
Time frame
at 2 years post end of enrollment4
NYHA class
NYHA I-IV at prespecified visits
Time frame
at 2 years post end of enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Source ClinicalTrials.gov