Cincinnati, OHNCT07194265Now EnrollingIRB Ready

Severe Aortic Stenosis Clinical Trial in Cincinnati, OH

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

Sponsored by Anteris Technologies Ltd.

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Expert Care in Cincinnati

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 Cincinnati, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cincinnati

    Convenient for OH 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 Cincinnati site if eligible
  4. 4Begin participation

About This Severe Aortic Stenosis Study in Cincinnati

Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years. After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'. Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.

Sponsor: Anteris Technologies Ltd.

Who Can Participate

Inclusion Criteria

Native Aortic Stenosis Cohorts:
The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
Subject understands the study requirements and the treatment procedure and provides written informed consent. ViV Registry Cohort:
Severe degeneration of a surgically implanted aortic bioprosthetic valve.
Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
Subject understands the study requirements and the treatment procedure and provides written informed consent.

Exclusion Criteria

Native Aortic Stenosis Cohorts:
Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
Evidence of an acute myocardial infarction 30 days before randomization.
AV is unicuspid, Type 0 bicuspid, or is non-calcified.
Severe total aortic regurgitation
Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
Pre-existing mechanical or bioprosthetic valve in any position.
Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
Active bacterial endocarditis in the last 3 months.
Estimated life expectancy (after TAVR) \<12 months.
Subject is not a candidate for both arms (investigational and control) of the study.
Subject belongs to a vulnerable population ViV Registry Cohort:
Anatomy precluding safe placement of DurAVR THV.
Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
Need for emergency surgery for any reason
GI bleeding within the past 3 months.
Active bacterial endocarditis in the last 3 months.
Estimated life expectancy (after TAVR) \<12 months.
Subject belongs to a vulnerable population.

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 Cincinnati?

Yes, this clinical trial (NCT07194265) has an active research site in Cincinnati, OH 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 Cincinnati, OH

If you're searching for severe aortic stenosis treatment options in Cincinnati, OH, this clinical trial (NCT07194265) 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 Cincinnati 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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