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A tiny sensor inside the lung could reveal hidden pressure problems after Life-Saving surgery

NCT ID NCT07758179

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study tests whether a small implanted sensor, called CardioMEMS, can continuously track blood pressure in the lung arteries after surgery for chronic thromboembolic pulmonary hypertension (CTEPH). The surgery, called pulmonary endarterectomy, can cure CTEPH, but some patients still have high blood pressure afterward. Currently, doctors check this with occasional invasive tests, which miss changes over time. The study will place the sensor during surgery and monitor pressure remotely to see when it stabilizes and how it relates to recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CardioMEMS™, a small implanted sensor that continuously measures blood pressure in the lung arteries
What this could lead to
If successful, this could show that continuous pressure monitoring helps doctors detect and manage residual pulmonary hypertension earlier after surgery, potentially improving recovery and long-term outcomes.
What could go wrong
This is a small, early feasibility study, so results may not apply broadly. The sensor stays in permanently and carries a small risk of blood clots or device-related issues, though these are reported to be low.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. \-

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Conditions

The condition(s) this trial relates to.

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