Morristown, NJNCT07309029Now EnrollingIRB Ready

Severe Aortic Stenosis Clinical Trial in Morristown, NJ

Access cutting-edge severe aortic stenosis treatment through this clinical trial at a research site in Morristown. Study-provided care at no cost to qualified participants.

Sponsored by Atlantic Health System

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Expert Care in Morristown

Access severe aortic stenosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related severe aortic stenosis treatment provided free

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Check if you qualify for this severe aortic stenosis clinical trial in Morristown, NJ

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Why Participate?

  • No-Cost Study Care

  • Local to Morristown

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Morristown site if eligible
  4. 4Begin participation

About This Severe Aortic Stenosis Study in Morristown

The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are: 1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery? 2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group. Participants will: * Be screened for eligibility based on hemodynamic status and anatomical complexity * Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR * Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography

Sponsor: Atlantic Health System

Who Can Participate

Inclusion Criteria

\- Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).
Hemodynamic Criteria
Major Criteria (Class III)
Systolic blood pressure \<90 mmHg or MAP\<60 mmHg
Need for vasopressors or inotropes to maintain MAP\>60 mmHg
Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation
Minor Criteria (Class II)
Left ventricular ejection fraction \<35%
Pulmonary hypertension (pulmonary artery systolic pressure \>60 mmHg) with right ventricular dysfunction
Pulmonary capillary wedge pressure \>30 mmHg
Anatomic criteria
Major Criteria (Type C)
Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)
Native or valve-in-valve TAVR requiring dual-leaflet modification
Severe bioprosthetic aortic regurgitation
Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score \>33)
Minor Criteria (Type B)
Native or valve-in-valve TAVR requiring single-leaflet modification
Severe commissural misalignment requiring leaflet modification
High-risk for coronary occlusion not amenable to leaflet modification
Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic valve area ≤0.5 cm2)

Exclusion Criteria

Age \<18 or pregnant
General absolute contraindications to TAVR
Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.
Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).
Pre-existing Impella treatment.
Onset of shock \>12 hours.
Preceding cardiac arrest with prolonged resuscitation (\>40 minutes).
Other severe concomitant disease with life expectancy \<6 months.
Participation in another trial with an intervention.
Any class I hemodynamic status
Type A anatomical complexity with class I or II hemodynamic status

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 Morristown?

Yes, this clinical trial (NCT07309029) has an active research site in Morristown, NJ 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.

Severe Aortic Stenosis Treatment Options in Morristown, NJ

If you're searching for severe aortic stenosis treatment options in Morristown, NJ, this clinical trial (NCT07309029) 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 Morristown research site is actively enrolling participants for this clinical trial. You'll receive care from experienced severe 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 severe aortic stenosis clinical trials near you to find additional studies recruiting in your area.

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