NCT07758179Not yet recruiting
Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension:
Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension: CardioMEMS-CPETH Study
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
Chronic thromboembolic pulmonary hypertension (CTEPH) is potentially curable by pulmonary endarterectomy (PEA), although a substantial proportion of patients develop residual pulmonary hypertension despite successful surgery. Currently, postoperative haemodynamic assessment relies on intermittent right heart catheterization, which does not provide information on the temporal evolution of pulmonary artery pressures during recovery. The CTEPH-CardioMEMS study is a prospective, single-centre observational study evaluating the feasibility and clinical utility of continuous haemodynamic monitoring using the CardioMEMS™ system implanted intraoperatively during PEA. The primary objective is to characterize the postoperative trajectory of mean pulmonary artery pressure (mPAP), determine the time to haemodynamic stabilization, and explore the relationship between continuous pressure monitoring and clinical, echocardiographic, invasive haemodynamic and functional recovery.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Hospital Universitario 12 de Octubre
- NCT number
- NCT07758179
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Oct 2026 to the primary completion date, 1 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Age \<18 years.
- Inability or unwillingness to provide written informed consent.
- Contraindication to CardioMEMS™ implantation according to the manufacturer's instructions for use or investigator judgement.
- Life expectancy \<1 year due to a non-cardiopulmonary comorbidity.
- Inability to perform remote transmissions or comply with scheduled follow-up.
- Any condition that, in the opinion of the investigators, may compromise patient safety, study participation or data quality.
- \-
Criteria the registry did not label
- Given the exploratory proof-of-concept nature of the study and the limited sample, a risk enrichment strategy will be applied. Whenever possible, patient selection will preferentially include individuals considered to be at increased risk of residual pulmonary hypertension after PEA. High-risk features include severe preoperative haemodynamic impairment (pulmonary vascular resistance ≥8 Wood units/645dyn.s.cm-5), predominantly distal thromboembolic disease on preoperative imaging, delayed referral for PEA (\>2 years from diagnosis), or clinical characteristics associated with pulmonary microvascular disease (including antiphospholipid syndrome, splenectomy, chronic inflammatory or haematological disorders, or previous malignancy). These features are intended to enrich the study population with patients more likely to develop clinically relevant haemodynamic trajectories and should not be interpreted as validated predictors of residual pulmonary hypertension.
- In addition, the multidisciplinary CTEPH team may recommend inclusion of patients who do not strictly fulfil the above enrichment features but are considered, based on an integrated assessment of clinical characteristics, imaging findings, haemodynamic profile and surgical considerations, to be at increased risk of residual pulmonary hypertension or likely to derive particular benefit from continuous haemodynamic monitoring. This decision will be made by consensus and documented prospectively before study inclusion.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
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