TTVR Early Feasibility Study

Launched by MEDTRONIC CARDIOVASCULAR · Jun 11, 2020

Keywords

ClinConnect Summary

The TTVR Early Feasibility Study is a research trial that aims to investigate a new treatment for a heart condition called tricuspid regurgitation, where the tricuspid valve does not close properly, leading to symptoms like shortness of breath and swelling. This trial is testing a device called the Intrepid transcatheter tricuspid valve replacement (TTVR) system, which is designed to replace the damaged valve using a minimally invasive approach. This means the procedure will be done through the blood vessels, making it easier on the body compared to traditional surgery.

To be eligible for this trial, participants should be experiencing symptoms despite taking heart medications and must be considered at risk for surgery. They should also have severe tricuspid regurgitation confirmed by heart imaging tests and should be able to attend follow-up visits after the procedure. Participants can expect to receive close monitoring during the trial and contribute to important research that may help others with similar heart conditions in the future. It's important to note that individuals with certain health issues or conditions may not be able to participate, as outlined in the study criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
• • Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
• • Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
• • New York Heart Association (NYHA) Function Class II or greater
• • Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
• • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
• • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
• Exclusion Criteria:
• • Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
• • Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
• • Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
• • Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
• • Echocardiographic evidence of severe right ventricular dysfunction
• • Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
• • Need for emergent or urgent surgery
• • Untreated clinically significant coronary artery disease requiring revascularization
• • Carcinoid tricuspid regurgitation