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Catheter Denervation of Pulmonary Arteries in Treatment of IPAH & SPAH

NCT02403908 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-31

No results posted yet for this study

Summary

The aim of research proposal is to assess and compare the safety and efficacy of radiofrequency denervation of pulmonary arteries on decrease in pulmonary vascular resistance and mean pulmonary artery pressure (MPAP) in 20 patients with IPAH (mean pulmonary artery pressure \>25 mmHg) and in 20 patients with secondary pulmonary hypertension due to pulmonary disease or due to left heart disease not responding optimally to medical therapy.

Conditions

  • Hypertension, Pulmonary

Interventions

DEVICE

nMARQ Circular and Crescent catheters

Radiofrequency denervation of right and left pulmonary arteries ostia and of main pulmonary artery \<2 mm proximal from both ostia of right and left pulmonary arteries.

Sponsors & Collaborators

  • Croatian Science Foundation

    collaborator OTHER_GOV

  • Clinical Hospital Centre Zagreb

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-01-31
Completion
2019-01-31

Countries

  • Croatia

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 NCT02403908 on ClinicalTrials.gov