Is NCT06608823 recruiting in Burlingame, CA?

Yes, NCT06608823 is currently recruiting participants at its Burlingame, CA location. This aortic regurgitation clinical trial is actively enrolling qualified participants.

How do I join the aortic regurgitation clinical trial in Burlingame?

To join this clinical trial in Burlingame, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Burlingame clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Aortic Regurgitation Clinical Trial in Burlingame, CA

Who Can Participate

Inclusion Criteria

Clinical indication for AVR for native valve predominant AR defined as:

Class I or II indication for AVR according to ACC/AHA or ESC/EACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR

AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage\

from AR with unanimous agreement from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR

The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve

Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion Criteria

Confirmed moderate (2+) or less AR severity by core laboratory evaluation

Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions

Subject is high-risk for SAVR as determined by the local heart team

Subject refuses SAVR as a treatment option

Subject refuses a blood transfusion

Subject is selected for aortic valve repair or aortic surgery

Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention

Subject unable to undergo pre-procedure CT scan analysis for annular sizing

Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected.

Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated

Hostile chest or conditions or complications from a prior surgery that would preclude safe reoperation (i.e., mediastinitis, radiation damage, chest wall abnormalities, adhesion of aorta or internal mammary artery (IMA) to the sternum)

Need for emergency surgery or TAVR for any reason

Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support

Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks

Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization

LVEF \&amp;lt;25% according to core laboratory measurement of resting echocardiogram at time of screening

Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory

Severe chronic liver disease (Child-Pugh C) or any active liver disease

Chronic Kidney Disease Stage 4 or 5 (\&amp;lt;30 cc/min/1.73 m2 or dialysis)

Severe Pulmonary Hypertension (pulmonary arterial systolic pressure

amp;amp;gt;2/3 systemic systolic pressure)

Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1

amp;amp;lt;50% predicted or need for chronic supplementary oxygen

Blood dyscrasia as defined: leukopenia (WBC \&amp;lt;3,000 Cells/μL), thrombocytopenia (platelet count \&amp;lt;50,000 Cells/μL), or anemia (hemoglobin \&amp;lt;9.0 g/dL) that is uncorrected prior to randomization

History of bleeding diathesis or coagulopathy that is not adequately treated

Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy

Any condition considered a contraindication to mechanical circulatory support

Uncontrolled atrial fibrillation (i.e., resting heart rate \&amp;gt;120 bpm)

Evidence of an acute myocardial infarction ≤30 days before the index AVR

Any percutaneous coronary or peripheral interventional procedure performed ≤30 days prior to AVR (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)

Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization

Prior stroke with residual modified Rankin Score ≥2

Stroke or transient ischemic attack (TIA) within 6 months of randomization

Body mass index (BMI) \&amp;lt;20 or \&amp;gt;50 kg/m2

Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries)

Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)

Other medical, social, or psychological conditions that in the opinion of the investigator preclude the subject from appropriate consent or adherence to the protocol required follow-up exams

Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements

Anatomical exclusion criteria (ANY of the following):

Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory

Native aortic annulus perimeter \&amp;lt;66 mm or \&amp;gt;90 mm per the core laboratory reading of baseline cardiac CT imaging

Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB)

Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation) that would preclude safe passage of the delivery system or cannulation and aortotomy for SAVR

According to the CRB, a combination of aortic root angulation (angle between the plane of the aortic valve annulus and horizontal plane/vertebrae), sinus size, and straight length of the aorta that will not allow safe device delivery and THV deployment

Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation

According to core laboratory evaluation, severe aortic stenosis

Uncorrected hypertrophic obstructive cardiomyopathy

Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation

Left ventricular thrombus

Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure

Complex coronary artery disease:

Unprotected left main coronary artery disease ≥50%

Syntax score \&amp;gt;32 (in the absence of prior revascularization)

Heart Team determines that optimal revascularization cannot be adequately performed with EITHER CABG at the time of SAVR OR PCI at least 30 days prior to THV implant.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Burlingame?

Yes, this clinical trial (NCT06608823) has an active research site in Burlingame, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Aortic Regurgitation Treatment Options in Burlingame, CA

If you're searching for aortic regurgitation treatment options in Burlingame, CA, this clinical trial (NCT06608823) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Burlingame research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic regurgitation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all aortic regurgitation clinical trials near you to find additional studies recruiting in your area.

Aortic Regurgitation Clinical Trial in Burlingame, CA

Expert Care in Burlingame

IRB Approved

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About This Aortic Regurgitation Study in Burlingame