Rochester, MNNCT06183684Now EnrollingIRB Ready

Tricuspid Regurgitation Clinical Trial in Rochester, MN

Access cutting-edge tricuspid regurgitation treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by Laplace Interventional, Inc

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Expert Care in Rochester

Access tricuspid regurgitation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tricuspid regurgitation treatment provided free

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Check if you qualify for this tricuspid regurgitation clinical trial in Rochester, MN

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for MN 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 Rochester site if eligible
  4. 4Begin participation

About This Tricuspid Regurgitation Study in Rochester

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Sponsor: Laplace Interventional, Inc

Who Can Participate

Inclusion Criteria

22 - 90 years of age at the time of the study procedure
Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.
Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.
Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

Exclusion Criteria

Estimated life expectancy of less than 12 months
PVR \>5 Wood units
Echocardiographic evidence of severe right ventricular dysfunction
Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemaker within 90 days prior to the study procedure
Stroke or other major cerebrovascular event within 90-days prior to index procedure
Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm3 or thrombocytosis (platelet count \>700,000 /mm3)
Current or planned pregnancy within next 12 months for women of childbearing potential
Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
Left ventricular ejection fraction (LVEF) \< 30%

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 Rochester?

Yes, this clinical trial (NCT06183684) has an active research site in Rochester, MN 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.

Tricuspid Regurgitation Treatment Options in Rochester, MN

If you're searching for tricuspid regurgitation treatment options in Rochester, MN, this clinical trial (NCT06183684) 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 Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tricuspid 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 tricuspid regurgitation clinical trials near you to find additional studies recruiting in your area.

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