International BPA Registry

Status:	Recruiting
Conditions:	High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	11/1/2018
Start Date:	March 2, 2018
End Date:	March 2, 2022
Contact:	Fabrizio Canonaco, Dr
Email:	fabrizio.canonaco@cteph-association.org
Phone:	+ 41 41 379 79 70

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).

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)

We found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200