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

NCT07758179 | Not Yet Recruiting FDA Device

• 1 other identifier: 26/460
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

chronic thromboembolic pulmonary hypertension; pulmonary endarterectomy; remote haemodynamic monitoring; CardioMEMS; right heart catheterisation.

Outcome Measures

Primary Outcomes (1)

• Time to stabilization mPAP

  The primary endpoint of the study will be the time from pulmonary endarterectomy (PEA) to stabilization of mean pulmonary artery pressure (mPAP), as assessed by continuous remote monitoring with the CardioMEMS™ system. Hemodynamic stabilization will be operationally defined as the first postoperative day on which the 7-day moving average of mPAP remains stable (variation \<10%) for three consecutive days, in the absence of any intercurrent clinical event or therapeutic intervention that could account for changes in pulmonary artery pressure.

  From PEA to 12 months

Study Arms (1)

Unique group

There is only one group

Device: CardioMEMS

Interventions

CardioMEMS DEVICE

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

Unique group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with a confirmed diagnosis of CTEPH evaluated at the multidisciplinary meeting of the Pulmonary Hypertension Unit (UHP) will be considered. In this meeting, treatment indication (PEA, BPA, and/or medical therapy) will be determined. During this session, candidates who are most likely to benefit from CardioMEMS™ implantation will be selected.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre: collaborator
• Complutense: collaborator
• Universidad Complutense de Madrid: collaborator

Central Study Contacts

Alejandro Cruz Utrilla, PhD, MD

CONTACT

+34 913 90 80 00; acruzutrilla@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08