International BPA Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Sponsor
- International CTEPH Association
- Enrollment
- 500
- Locations
- 18
- Primary Endpoint
- Safety as assessed by BPA-associated complications
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 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).
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Safety as assessed by BPA-associated complications
Time Frame: Min. 2 years
Efficacy as assessed by change in mPAP
Time Frame: Min. 2 years
Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics
Efficacy as assessed by change in PVR
Time Frame: Min. 2 years
Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics
Secondary Outcomes
- At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals(Min. 2 years)
- Analyze patient selection criteria for BPA across sites at the end of recruitment(Min. 2 years)
- Health care resource use required to complete BPA(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up(Min. 2 years)
- Analyze the impact of PH targeted medical treatment on key patient outcomes(Min. 2 years)
- Compare volume of BPA cases across regions and case load at the end of recruitment(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as assessed by technical limits(Min. 2 years)
- Analyze the use of PH targeted medical therapy after BPA(Min. 2 years)
- Analyze the use of PH targeted medical therapy before BPA(Min. 2 years)