International BPA Registry

International CTEPH Association

Status: Completed

Conditions: CTEPH; Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: Balloon pulmonary angioplasty

Study type: Observational

Funder types: Other

Identifiers

NCT03245268

BPA Registry

Details and patient eligibility

About

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).

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)