New York, NYNCT06689839Now EnrollingIRB Ready

Aortic Stenosis Treated With TAVI Clinical Trial in New York, NY

Access cutting-edge aortic stenosis treated with tavi treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by EnCompass Technologies, Inc.

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Expert Care in New York

Access aortic stenosis treated with tavi specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic stenosis treated with tavi treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY 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 New York site if eligible
  4. 4Begin participation

About This Aortic Stenosis Treated With TAVI Study in New York

The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)

Sponsor: EnCompass Technologies, Inc.

Who Can Participate

Inclusion Criteria

Age ≥ 50 years.
Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician.
Patient is willing and able to comply with protocol-specified follow-up evaluations.
Patient is able and willing to provide written informed consent.
Patient meets all criteria for use of control device (Sentinel device, per IFU). Key

Exclusion Criteria

General Exclusion Criteria:
Patient requires an urgent or emergent TAVR procedure.
Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
Prior prosthetic heart valve in any position.
Known intracardiac thrombus.
Active infection or endocarditis.
Patient is contraindicated for anti-platelet and/or anticoagulant therapy.
Patient refuses blood transfusion.
Renal insufficiency (creatinine \> 2.5 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening.
Patients with hepatic failure (Child-Pugh class C).
Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 30%.
Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Neurological Exclusion Criteria:
Modified Rankin Scale (mRS) ≥ 2 at screening.
Cerebrovascular event including TIA within 6 months of the procedure.
Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
Patient has severe visual, auditory, or learning impairment.
Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Magnetic Resonance Imaging Exclusion Criteria:
Contraindications to MRI (participants with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
High risk of complete AV block after TAVR, with the need of permanent pacemaker.
Claustrophobia precluding MRI scanning. Anatomical and CT Exclusion Criteria:
Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.
Presence of cardiovascular implant in aorta and/or peripheral access vessels.
Access vessels with excessive tortuosity.
Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.

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 New York?

Yes, this clinical trial (NCT06689839) has an active research site in New York, NY 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 Stenosis Treated With TAVI Treatment Options in New York, NY

If you're searching for aortic stenosis treated with tavi treatment options in New York, NY, this clinical trial (NCT06689839) 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 New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic stenosis treated with tavi 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 stenosis treated with tavi clinical trials near you to find additional studies recruiting in your area.

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