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V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure

NCT03775161 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-05-30

No results posted yet for this study

Summary

The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.

Conditions

Interventions

DEVICE

V-LAP™ System

Delivery of the V-LAP™ implant via a catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.

Sponsors & Collaborators

  • Horizon 2020 - European Commission

    collaborator OTHER

  • Vectorious Medical Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Horst Sievert, Prof. Dr. · Director and Founder of CardioVasculäres Centrum Frankfurt

  • Carlo Di Mario, Professor · University of Florence and Careggi University Hospital

  • Francisco Leyva, Professor · Consultant Cardiologist, Queen Elizabeth Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany
  • Italy

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 NCT03775161 on ClinicalTrials.gov