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

NCT06147336 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

V-LAP™ SYSTEM

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.

Sponsors & Collaborators

  • Vectorious Medical Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Rami Kahwash, Prof. · Ohio State University

  • Ramesh Emani, Dr. · Christ Hospital - Linder Research Institute

  • Sandip Zalawadiya, Dr. · Vanderbilt University Medical Center

  • Nir Ayalon, Dr. · Boston Medical Center

  • Michael DiVita, Dr. · NYU Langone

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2025-06-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147336 on ClinicalTrials.gov