Is NCT06455787 recruiting in La Jolla, CA?

Yes, NCT06455787 is currently recruiting participants at its La Jolla, CA location. This aortic valve regurgitation clinical trial is actively enrolling qualified participants.

How do I join the aortic valve regurgitation clinical trial in La Jolla?

To join this clinical trial in La Jolla, 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 La Jolla 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 Valve Regurgitation Clinical Trial in La Jolla, CA

About This Aortic Valve Regurgitation Study in La Jolla

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

Who Can Participate

Inclusion Criteria

Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher

Severe AR, defined as follows, as assessed by Imaging Core Laboratory: A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4) B. OR, if indeterminate AR, by TTE, ANY ONE of the following: i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index \[LVEDVi\]) \>105 mL/m\^2 for men or LVEDVi \>96 mL/m\^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL/m\^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4)

High risk for surgery as judged by a multi-disciplinary heart team

Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic

Exclusion Criteria

Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site. Exclusion Criteria:

Previous prosthetic aortic valve (bioprosthesis or mechanical) implant

Aortic valve stenosis \> moderate\

Severe mitral valve or tricuspid valve regurgitation\

Severe mitral valve or tricuspid valve stenosis\

Active infection, including infective endocarditis

Cardiac imaging evidence of cardiac mass, thrombus or vegetation

Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy

Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis

Liver disease (cirrhosis of the liver \[Child-Pugh Class B or C\])

Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mcL), thrombocytopenia (platelet count \<50,000 cells/mcL), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis coagulopathy, or hypercoagulable state (unless therapeutically stable)

Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated

Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)\

Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure

Acute myocardial infarction within 30 days prior to index procedure

PCI within 30 days prior to index procedure

Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention

Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure

Uncontrolled atrial fibrillation

Severe right ventricular (RV) dysfunction\

Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)

Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2

Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure

Cardiogenic shock defined as systolic blood pressure \<90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg

Patient requires mechanical circulatory support within 30 days prior to index procedure

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

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

Participation in another investigational study that has not reached its primary endpoint

Considered to be part of a vulnerable population

As assessed by Imaging Core Laboratory Anatomic Exclusions:

Ascending Aortic diameter \>5 cm\

Aortic Annulus Perimeter \<57 mm or \>104 mm\

Inappropriate anatomy for femoral introduction and delivery of the study system

Left ventricular end-diastolic diameter (LVEDD) \>75 mm\

Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\

Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk

Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus

Abdominal/thoracic aortic aneurysm ≥5.0 cm\

Aorto-iliac disease requiring intervention to facilitate delivery of access sheath

Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \>80⁰

Non-native anatomy in aortic zones 0A \& 0B (aortic valve annulus to the distal margin of the right pulmonary artery); 0C (to innominate) only if deemed unfavorable by the Study Screening Committee

As assessed by Imaging Core Laboratory

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 La Jolla?

Yes, this clinical trial (NCT06455787) has an active research site in La Jolla, 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 Valve Regurgitation Treatment Options in La Jolla, CA

If you're searching for aortic valve regurgitation treatment options in La Jolla, CA, this clinical trial (NCT06455787) 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 La Jolla research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic valve 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 valve regurgitation clinical trials near you to find additional studies recruiting in your area.

Aortic Valve Regurgitation Clinical Trial in La Jolla, CA

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