Chronic Thromboembolic Pulmonary HypertensionCARDIOMEMSCTPHNCT07758179
Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension:
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Residual Pulmonary Hypertension, run by Hospital Universitario 12 de Octubre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Residual Pulmonary Hypertension
- What is being tested?
- CardioMEMS
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
- 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. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension: CardioMEMS-CPETH Study
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.
Read the detailed description
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.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a potentially curable form of pulmonary hypertension caused by persistent organized thromboembolic obstruction of the pulmonary arteries together with secondary pulmonary microvascular remodeling. Pulmonary endarterectomy (PEA) is the treatment of choice for operable disease and results in normalization of pulmonary haemodynamics in many patients. However, a substantial proportion of patients develop persistent or residual pulmonary hypertension after surgery, which is associated with persistent symptoms, right ventricular dysfunction, need for additional balloon pulmonary angioplasty or pulmonary hypertension-targeted therapy, and worse long-term outcomes.
Current postoperative follow-up combines clinical evaluation, laboratory biomarkers, transthoracic echocardiography, pulmonary function tests, cardiopulmonary exercise testing (CPET), and right heart catheterization (RHC). Although RHC remains the reference standard for haemodynamic assessment, it provides only isolated measurements and cannot characterize the dynamic haemodynamic changes occurring during the early postoperative period. Consequently, the temporal pattern of pulmonary artery pressure recovery following PEA remains largely unknown.
The CardioMEMS™ HF System is a wireless implantable pulmonary artery pressure sensor that enables continuous remote monitoring of pulmonary artery pressures through daily measurements. Although its safety and clinical benefit have been demonstrated in patients with heart failure, experience in patients with CTEPH is currently lacking. In this study, the device will be implanted intraoperatively under direct surgical visualization during PEA, avoiding the need for an additional percutaneous implantation procedure.**
The CTEPH-CardioMEMS study is a prospective, single-centre, exploratory observational study designed to characterize the postoperative trajectory of mean pulmonary artery pressure after PEA. The primary endpoint is the time from surgery to haemodynamic stabilization, defined according to a pre-specified longitudinal criterion based on daily CardioMEMS™ measurements. Secondary objectives include evaluating the relationship between continuous haemodynamic data and clinical status, laboratory findings, right ventricular remodeling assessed by echocardiography, invasive haemodynamics obtained by RHC, functional capacity assessed by CPET, quality of life, need for pulmonary hypertension-specific therapy, balloon pulmonary angioplasty, and clinical outcomes. Given its pilot nature, the study incorporates a risk-enrichment strategy aimed at preferentially including patients considered to be at increased risk of residual pulmonary hypertension, while maintaining consecutive screening of all patients discussed by the multidisciplinary CTEPH team. The study is intended to provide the first comprehensive description of continuous haemodynamic recovery after PEA, assess the feasibility and safety of CardioMEMS™ monitoring in this population, and generate data to support future multicentre confirmatory studies
- Being tested
- CardioMEMS
- Keywords
- chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, remote haemodynamic monitoring, CardioMEMS, right heart catheterisation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Unique group | There is only one group Receives: Device: CardioMEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From PEA to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Complutense, Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Alejandro Cruz Utrilla, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758179
- Sponsor's protocol ID
- 26/460
- Other IDs
- 26/460
- Acronym
- CARDIOMEMSCTPH
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension: CardioMEMS-CPETH Study
- ClinicalTrials.gov ID
- NCT07758179
- Acronym / sponsor ID
- CARDIOMEMSCTPH / 26/460
- Keywords
- chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, remote haemodynamic monitoring, CardioMEMS, right heart catheterisation.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Collaborators
- Complutense, Universidad Complutense de Madrid
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a potentially curable form of pulmonary hypertension caused by persistent organized thromboembolic obstruction of the pulmonary arteries together with secondary pulmonary microvascular remodeling. Pulmonary endarterectomy (PEA) is the treatment of choice for operable disease and results in normalization of pulmonary haemodynamics in many patients. However, a substantial proportion of patients develop persistent or residual pulmonary hypertension after surgery, which is associated with persistent symptoms, right ventricular dysfunction, need for additional balloon pulmonary angioplasty or pulmonary hypertension-targeted therapy, and worse long-term outcomes.
Current postoperative follow-up combines clinical evaluation, laboratory biomarkers, transthoracic echocardiography, pulmonary function tests, cardiopulmonary exercise testing (CPET), and right heart catheterization (RHC). Although RHC remains the reference standard for haemodynamic assessment, it provides only isolated measurements and cannot characterize the dynamic haemodynamic changes occurring during the early postoperative period. Consequently, the temporal pattern of pulmonary artery pressure recovery following PEA remains largely unknown.
The CardioMEMS™ HF System is a wireless implantable pulmonary artery pressure sensor that enables continuous remote monitoring of pulmonary artery pressures through daily measurements. Although its safety and clinical benefit have been demonstrated in patients with heart failure, experience in patients with CTEPH is currently lacking. In this study, the device will be implanted intraoperatively under direct surgical visualization during PEA, avoiding the need for an additional percutaneous implantation procedure.**
The CTEPH-CardioMEMS study is a prospective, single-centre, exploratory observational study designed to characterize the postoperative trajectory of mean pulmonary artery pressure after PEA. The primary endpoint is the time from surgery to haemodynamic stabilization, defined according to a pre-specified longitudinal criterion based on daily CardioMEMS™ measurements. Secondary objectives include evaluating the relationship between continuous haemodynamic data and clinical status, laboratory findings, right ventricular remodeling assessed by echocardiography, invasive haemodynamics obtained by RHC, functional capacity assessed by CPET, quality of life, need for pulmonary hypertension-specific therapy, balloon pulmonary angioplasty, and clinical outcomes. Given its pilot nature, the study incorporates a risk-enrichment strategy aimed at preferentially including patients considered to be at increased risk of residual pulmonary hypertension, while maintaining consecutive screening of all patients discussed by the multidisciplinary CTEPH team. The study is intended to provide the first comprehensive description of continuous haemodynamic recovery after PEA, assess the feasibility and safety of CardioMEMS™ monitoring in this population, and generate data to support future multicentre confirmatory studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique group | – | Device: CardioMEMSThere is only one group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioMEMSCardioMEMS™ 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 | Device | Unique group |
Primary outcome
Time to stabilization mPAP
Time frame: From PEA to 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Residual Pulmonary Hypertension, run by Hospital Universitario 12 de Octubre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Cruz Utrilla, PhD, MD (+34 913 90 80 00, acruzutrilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stabilization mPAP (time frame: From PEA to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.