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NCT07758179

Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension:

Sponsor: Hospital Universitario 12 de Octubre

View on ClinicalTrials.gov

Summary

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.

Official title: Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension: CardioMEMS-CPETH Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2029-10-01

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Chronic Thromboembolic Pulmonary Hypertension Residual Pulmonary Hypertension

Interventions

DEVICE

CardioMEMS

CardioMEMS™ implantation: The sensor will be implanted intraoperatively during pulmonary endarterectomy, under direct vision, into a subsegmental pulmonary artery branch with a minimum diameter of 7 mm. Implantation in this manner requires no additional percutaneous procedure and does not add to surgical risk; direct-vision placement allows accurate positioning within a thrombus-free segment. The device is intended to remain permanently in situ. All patients with CTEPH continue lifelong anticoagulation; although published device-related thrombosis/embolism rates are low (under 1 per 1000 implants), these data derive from cohorts without mandatory lifelong anticoagulation, and safety in this specific population is therefore a pre-specified objective of the study.7

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. Inclusion criteria 1. Age ≥18 years. 2. Confirmed diagnosis of CTEPH according to current international guidelines. 3. Multidisciplinary indication for pulmonary endarterectomy. 4. Considered suitable for intraoperative CardioMEMS™ implantation. 5. Ability to comply with remote monitoring and scheduled follow-up. 6. Written informed consent. Exclusion criteria 1. Age \<18 years. 2. Inability or unwillingness to provide written informed consent. 3. Contraindication to CardioMEMS™ implantation according to the manufacturer's instructions for use or investigator judgement. 4. Life expectancy \<1 year due to a non-cardiopulmonary comorbidity. 5. Inability to perform remote transmissions or comply with scheduled follow-up. 6. Any condition that, in the opinion of the investigators, may compromise patient safety, study participation or data quality. \-