A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Vectorious Medical Technologies Ltd.
Study ID
NCT06147336
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • V-LAP™ SYSTEM — DEVICE
    Delivery of the V-LAP™ implant by right heart catheterization. A catheter-based approach in a trans-septal puncture procedure, fixated within the inter-atrial septum.

Study Details

The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.

Key Dates

Start date
Jun 11, 2024
Status verified
May 2025
Primary completion
Jun 30, 2025
Completion
Apr 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: V-LAP™ System
    Heart failure subjects - Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home and will be trained on the use of the device for self-management.

Primary Outcome Measure

LAP measurement [ Time Frame: Up to 12 months post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
One Boston Medical Center PlaceBostonMassachusetts02118
Nir Ayalon, Dr.
[email protected]
+1 (781) 336-8755
Nir Ayalon, Dr. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
One Boston Medical Center Place· Boston, MA

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