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The V-Wave Shunt: FIM Safety and Feasibility Study

NCT01965015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-10-07

No results posted yet for this study

Summary

The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Implantation of the V-Wave inter-atrial shunt

Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach

Sponsors & Collaborators

  • V-Wave Ltd

    lead INDUSTRY

Principal Investigators

  • Rotem Katzenellenbogen · V-Wave Medical

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2016-01-21
Completion
2017-10-15

Countries

  • Germany
  • Israel
  • Spain

Study Locations

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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 NCT01965015 on ClinicalTrials.gov