Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06368401




Registration number
NCT06368401
Ethics application status
Date submitted
7/04/2024
Date registered
16/04/2024
Date last updated
16/04/2024

Titles & IDs
Public title
A First in Human Study for the Versa Device for Tricuspid Regurgitation
Scientific title
Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System
Secondary ID [1] 0 0
TP_01428
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Versa Implant

Experimental: Implant - 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.


Treatment: Devices: Versa Implant
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute Procedural Success
Timepoint [1] 0 0
Immediately after the procedure
Primary outcome [2] 0 0
Incidence of major adverse events (MAE)
Timepoint [2] 0 0
(up to 7 days) from date of procedure to date of patient discharge from hospital
Secondary outcome [1] 0 0
Tricuspid Regurgitation Severity Change
Timepoint [1] 0 0
90 days

Eligibility
Key inclusion criteria
- 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- Life expectancy of less than 12 months independent of tricuspid valvular disease.

- Subject currently participating in another clinical study (not yet completed primary
endpoint).

- Pregnant or nursing subjects or those who plan pregnancy during the study.

- The presence of anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the eye of the investigator, limits the subject's
ability to participate in the clinical investigation or comply with follow-up
requirements.

- Absence of appropriate venous access.

- Unwillingness to complete the required follow-up visits.

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Versa Vascular, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06368401
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Webster, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aaron Grogan
Address 0 0
Country 0 0
Phone 0 0
650 265 8123
Fax 0 0
Email 0 0
aaron@versavascular.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06368401