CLC-0001
Research type
Research Study
Full title
A First in Human multi-center, open label, prospective study to evaluate the safety, usability and performance of the V-LAP system
IRAS ID
245964
Contact name
Francisco Leyva
Contact email
Sponsor organisation
Vectorious Medical Technologies
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
This is a prospective, international, multicenter, single-arm, first in Human feasibility study to assess the safety, usability, and performance of the V-LAP System when implanted in patients with severe chronic HF.
The V- LAP™ System is indicated for wirelessly measuring and monitoring left atrial pressure (LAP) in chronic ACC/AHA Stage C, New York Heart Association (NYHA) Class III or ambulatory Class IV heart failure (HF) patients who have been hospitalized for HF in the previous year or elevated ambulatory levels of BNP/NT-proBNP. Hemodynamic data can be used by physicians for pressure-guided medical management of these patients, with the goal of reducing hospitalizations.
Subject population: Subjects with chronic ACC/AHA Stage C, NYHA functional class III, or ambulatory Class IV HF, who have a history of hospitalizations for worsening HF or elevated ambulatory levels of BNP/NT-proBNP.
Subjects will be followed at the clinic at 1, 3, 6, 12, 24 and 36 months post implant procedure.
At the 3M follow-up visit, a right heart catheterization (RHC) for PCWP measurement with simultaneous assessment of direct LAP data from the V-LAPIM is performed. Follow up use of LAP data for treatment will be according to physician’s discretion.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0280
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion