Status:
COMPLETED
International BPA Registry
Lead Sponsor:
International CTEPH Association
Conditions:
Chronic Thromboembolic Pulmonary Hypertension
CTEPH
Eligibility:
All Genders
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03245268
Start Date
March 2 2018
End Date
March 31 2022
Last Update
June 10 2022
Active Locations (18)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195