International BPA Registry

a study on Chronic Thromboembolic Pulmonary Hypertension High Blood Pressure

Summary

at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).

Keywords

Chronic Thromboembolic Pulmonary Hypertension CTEPH Balloon pulmonary angioplasty BPA Hypertension, Pulmonary

Eligibility

You can join if…

  • Diagnosis with CTEPH according to the following criteria:
  • Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease
  • Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
  • Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
  • Naïve to BPA treatment
  • Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. Enrollment must occur before any BPA session
  • Willing to provide informed consent

You CAN'T join if...

  • BPA treatment prior to enrollment
  • Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
  • Targeted BPA treatment lesion other than from WHO group IV (CTEPH)

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • Mayo Clinic accepting new patients
    Rochester Minnesota 55905 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
International CTEPH Association
Links
Website of the International CTEPH Association
ID
NCT03245268
Study Type
Observational [Patient Registry]
Last Updated