An observational study in Chronic Thromboembolic Pulmonary Hypertension and Residual Pulmonary Hypertension, sponsored by Hospital Universitario 12 de Octubre. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Hospital Universitario 12 de Octubre · Observational
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 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
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 30 is below the median of 110 across 381 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Hospital Universitario 12 de Octubre is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 ). These features are intended to enrich the study population with patients more likely to develop 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 . Exclusion criteria
Any condition that, in the opinion of the investigators, may compromise patient safety, study participation or data quality.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There is only one group
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
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.
Time frame: From PEA to 12 months
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 143 non-industry observational studies under Hypertension, Pulmonary, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 167. This study's planned 24 months is below that.
Counting every sponsor, half of 168 studies reached it within 59 months; a quarter within 24 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario 12 de Octubre