Is NCT07278310 recruiting in Atlanta, GA?

Yes, NCT07278310 is currently recruiting participants at its Atlanta, GA location. This symptomatic severe native aortic stenosis clinical trial is actively enrolling qualified participants.

Is participation in this Atlanta 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.

Symptomatic Severe Native Aortic Stenosis Clinical Trial in Atlanta, GA

Q: How do I join the symptomatic severe native aortic stenosis clinical trial in Atlanta?

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

Who Can Participate

Inclusion Criteria

Subjects are eligible for entry in this study if ALL the following conditions are met:

Age ≥ 18 years

Symptomatic, severe native calcific aortic stenosis in subjects at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 or Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index \<0.25

New York Heart Association Functional Class ≥ 2

Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)

Eligible for transfemoral delivery of a TAVR

Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm or 29 mm transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (23mm: 330- 440 mm2 , 26mm: 430-550 mm2, 29mm: 540-690 mm2)

Understands the study requirements and the treatment procedures and provides written informed consent

Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria

Subjects will be excluded for entry in this study if ANY of the following conditions are met: Anatomical

Cardiac anatomy precluding safe placement of a transcatheter aortic valve.

Iliofemoral vessel characteristics (vessel diameter \<5.5mm for smaller THV systems \[20-26mm valve sizes\] or \<6.0mm for larger THV systems \[29mm or larger valve sizes\]) that would preclude safe placement of commercially available transcatheter aortic valves (SAPIEN 3 or Evolut)

Pre-existing prosthetic heart valve or ring except in the mitral position.

Unicuspid aortic valve

Severe aortic regurgitation (\>3+)

Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.

Moderate to severe mitral stenosis.

Hypertrophic obstructive cardiomyopathy (HOCM)

Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.

Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5.5 cm or greater or ascending aortic aneurysm defined as maximal luminal diameter 5 cm or greater. Clinical

Evidence of an acute myocardial infarction ≤ 30 days before enrollment.

Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure

Blood dyscrasias as defined: leukopenia (WBC \< 3000 cell/mL, anemia (Hgb \< 9 g/dL), thrombocytopenia (platelet count \< 50,000 cells/mL), history of bleeding diathesis or coagulopathy.

Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization

Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.

Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment

Need for emergency surgery for any reason

Ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 25% as measured by resting echocardiogram

Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).

Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment

Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis

GI bleeding within the past 3 months

Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen

History of cirrhosis or any active liver disease

Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm \> 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system

Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)

A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, ticlopidine and clopidogrel, contrast media, nickel, cobalt ,chromium, titanium, molybdenum, rhenium, polyethylene materials.

Ongoing sepsis, including active endocarditis

BMI \> 50 kg/m2

Subject refuses a blood transfusion

Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions

Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent

Severe dementia (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)

Currently participating in an investigational drug or another investigational device trial

Subject is contraindicated for cardiac CT

Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).

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 Atlanta?

Yes, this clinical trial (NCT07278310) has an active research site in Atlanta, GA 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.

Symptomatic Severe Native Aortic Stenosis Treatment Options in Atlanta, GA

If you're searching for symptomatic severe native aortic stenosis treatment options in Atlanta, GA, this clinical trial (NCT07278310) 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 Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced symptomatic severe native aortic stenosis 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 symptomatic severe native aortic stenosis clinical trials near you to find additional studies recruiting in your area.

Symptomatic Severe Native Aortic Stenosis Clinical Trial in Atlanta, GA

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