A First in Human Study for the Versa Device for Tricuspid Regurgitation

NCT06368401 | Active Not Recruiting

• 1 other identifier: TP_01428
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• Acute Procedural Success

  Successful in Versa Vascular Device implantation, and residual TR grade equivalent to a reduction of at least 1 grade of TR when compared to TR evaluated prior to implantation of the Versa Vascular Device.

  Immediately after the procedure

• Incidence of major adverse events (MAE)

  Freedom from procedure and/or device related Major Adverse Events (MAE). MAE are defined as all-cause mortality, reoperation, or reintervention for tricuspid regurgitation prior to hospital discharge.

  (up to 7 days) from date of procedure to date of patient discharge from hospital

Secondary Outcomes (1)

• Tricuspid Regurgitation Severity Change

  90 days

Study Arms (1)

Implant

EXPERIMENTAL

Participants who pass all screening criteria will undergo a percutaneous procedure for the implantation of a permanent tricuspid repair device. Participants will be followed for 1 year to evaluate the safety and feasibility of the Versa System procedure and the Versa Tricuspid Repair Implant.

Device: Versa Implant

Interventions

Versa Implant DEVICE

The Versa Vascular Implant and Delivery System consists of a percutaneously delivered, permanent right-atrial implant and the delivery catheter that is used to first position the implant over the native valve orifice and to then place the implant.

Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tricuspid regurgitation (TR) associated symptoms despite optimal medical treatment.
• TR ≥ 3 as determined by the assessment of a transthoracic echocardiogram or transesophageal echocardiogram.
• The local multi-disciplinary heart team agrees that the participant is a poor candidate for surgery.
• Age ≥ 18 years at the time of consent.
• Ability and willingness to provide written informed consent prior to any study related procedure(s).

You may not qualify if:

• Severe pulmonary hypertension.
• Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
• Any condition that would interfere with the Versa procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude successful device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of Versa implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle), tricuspid valve anatomy non-evaluable by echocardiography.
• Known allergy to antiplatelet therapy, heparin, or to device materials.
• Femoral venous mass or thrombus or vegetation.
• Tricuspid valve anatomy not compatible with the Versa implant
• Undergone any heart valve surgery within prior 60 days.
• Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 4.0 cm2.
• Severe mitral regurgitation.
• Left Ventricular Ejection Fraction (LVEF) ≤ 20%
• Active endocarditis, other ongoing infection requiring antibiotic therapy.
• Myocardial infarction or percutaneous coronary intervention within prior 30 days.
• Cardiogenic shock or the need for inotropic support or hemodynamic support device (e.g., intra-aortic balloon pump).
• Cerebrovascular Accident (CVA) within prior 30 days
• Active gastrointestinal (GI) bleeding

Sponsors & Collaborators

• Versa Vascular, Inc: lead
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (2)

Pontificia Universidad Católica

Santiago, Chile

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Mark Webster, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 16, 2024
• Study Start: August 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: October 2, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); NZ (1)