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

NCT07758179 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-08-11

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre

    collaborator UNKNOWN

  • Complutense

    collaborator UNKNOWN

  • Universidad Complutense de Madrid

    collaborator OTHER

  • Hospital Universitario 12 de Octubre

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-10-01
Completion
2029-10-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758179 on ClinicalTrials.gov