Pulmonary Embolism and ThrombosisTiPENCT07650435
Thrombectomy in Pulmonary Embolism
An observational study of Pulmonary Embolism and Thrombosis, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism and Thrombosis
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2026to 11 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PE <14 days and evidence of right heart strain
Who may be able to join
- Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
- Patients who present with computed tomography confirmed pulmonary embolism
- Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
- Date of computed tomography imaging from within a two-year period
- Patient is greater than or equal to 18 years of age
- Informed consent obtained
Show all 14Show fewer
- Evidence of cardiac dysfunction (either biochemical or imaging features of right heart strain)
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- Patients who present with CT confirmed PE
- Defined as intermediate or high-risk PE (according to ESC guidelines1)
- Date of CT imaging from within a two-year period
- Patient is ≥ 18 years of age
- Informed consent obtained
- Evidence of cardiac dysfunction (Either biochemical or imaging features of RHS)
Who cannot join
- Known serious, uncontrolled sensitivity to radiographic agents
- Computed tomography not available to evaluate pulmonary embolism
- Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
- Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
- Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- 1. Known serious, uncontrolled sensitivity to radiographic agents 2. CT not available to evaluate PE 3. Low Risk PE as defined by ESC guidelines1 4. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 5. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Plymouth NHS Trust
Plymouth
Paul Jenkins BMBS, Bsc, 01752438000, plh-tr.tipe@nhs.net
About this study
Official title: Prospective Observational Study to Evaluate the Use of Computer-Aided Vacuum Thrombectomy Within the Context of Intermediate and High-Risk Pulmonary Embolism
Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.
Read the detailed description
Acute intermediate-risk pulmonary embolism (PE) and high-risk PE can be life threatening. The incidence of PE is increasing , and patients who survive the acute presentation may experience significant morbidity including reduced exercise tolerance, and decreased quality of life (QoL). Often patients are treated with anticoagulation to stop the clot getting worse and encourage the body to slowly break up the clot. However in more severe cases thrombolysis medication can be given to actively break up the clot. Catheter directed thrombolysis can be used to target the lytic medication into the pulmonary arteries and reduced the systemic effects. Percutaneous thrombectomy is a newer treatment option that aspirates the clot, providing a faster and potentially lytic free solution to sick patients. Pulmonary artery thrombectomy (PAT) is a treatment option that is variably utilised and has unclear evidence base . The penumbra device uses a computer modulated vacuum aspiration system to both fatigue, breakup and aspirate the clot. This has been shown to be safe and effective in small cohorts. CAVT can prevent acute hemodynamic decompensation, alleviate acute PE-related symptoms, accelerate right ventricular recovery, and improve quality of life as measured by patient-reported outcomes (PROs). Despite existing literature addressing clinical outcomes with PE treatment, comprehensive data on PE-related morbidity, PROs and longer-term outcomes after mechanical thrombectomy are still lacking.
- Conditions
- Pulmonary Embolism and Thrombosis
- Keywords
- PE, Thrombectomy
- Medical subject headings
- Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAVT thrombectomy | PE with evidence of right heart strain and thrombectomy with 16Fr CAVT | |
| PE with evidence of right heart strain | PE with evidence of right heart strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV/RV ratio
- To evaluate the effectiveness of PE CAVT as a treatment for intermediate and high-risk PE as measured by change pulmonary arterial pressure and in RV/LV (Right Ventricle to Left Ventricle diameter) ratio at 48 (+ 48 /- 24) hours post procedure.
Measured: 48 (+ 48 /- 24) hours post procedure.
Morbidity and mortality
Ascertain the mortality and morbidity profile for CAVT within intermediate and high-risk PE, within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Measured: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start11 May 2026
- Primary completion11 Dec 2029 (estimated)
- Study completion11 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism and ThrombosisStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650435
- Sponsor's protocol ID
- 24RAD100
- Other IDs
- 362530
- Acronym
- TiPE
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for data sharing can be made after publication of the primary results paper. Requests should be made to the Chief Investigator in the first instance. Requesters will be asked to complete an application form detailing specific requirements, rationale, and proposed usage. The CI and study sponsor (including the sponsor's Research Governance Manager (or deputy), the Information Governance Team, Calidcott Guardian, IM\&T Security Officer and the researcher funder, as appropriate) will review all requests. Consideration will be given to: 1. The viability and suitability of the request 2. Appropriate steps have been taken to minimise the risk of identifying participants 3. Data security policies and procedures of recipient organisation (including country if abroad) and other regulatory requirements are applicable 4. The credentials of the requestor Where access to requested data is granted, requesters organisation must sign a data sharing agreement before they can access any data.
Publications
11. National institute of Clinical Excellence. Pulmonary embolism: what are the risk factors. NICE guidelines. https://cks.nice.org.uk/topics/pulmonary-embolism/background-information/risk-factors/
Noble S, Lewis R, Whithers J, Lewis S, Bennett P. Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study. BMJ Open. 2014 Apr 2;4(4):e004561. doi: 10.1136/bmjopen-2013-004561.
PubMed 24694625Danielsbacka JS, Rostberg L, Olsen MF, Mannerkorpi K. "Whole life changed" - Experiences of how symptoms derived from acute pulmonary embolism affects life. A qualitative interview study. Thromb Res. 2021 Sep;205:56-62. doi: 10.1016/j.thromres.2021.07.004. Epub 2021 Jul 5.
PubMed 342470988. Perkowski, Paul et al Computer-aided Mechanical Aspiration Thrombectomy with the Indigo Lightning 12 Aspiration System for the Treatment of Acute Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.Journal of Vascular Surgery, Volume 77, Issue 4, 52S - 53S
Moriarty JM, Dohad SY, Schiro BJ, Tamaddon H, Heithaus RE, Iliadis EA, Dexter DJ 2nd, Shavelle DM, Leal SRN, Attallah AS, West FM, Keeling WB, Sharp ASP, Weinberg I. Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study. J Vasc Interv Radiol. 2024 Aug;35(8):1154-1165.e6. doi: 10.1016/j.jvir.2024.04.028. Epub 2024 May 9.
PubMed 38729421Mathews SJ. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration. Tex Heart Inst J. 2021 Nov 1;48(5):e217571. doi: 10.14503/THIJ-21-7571. No abstract available.
PubMed 34911082Gotzinger F, Lauder L, Sharp ASP, Lang IM, Rosenkranz S, Konstantinides S, Edelman ER, Bohm M, Jaber W, Mahfoud F. Interventional therapies for pulmonary embolism. Nat Rev Cardiol. 2023 Oct;20(10):670-684. doi: 10.1038/s41569-023-00876-0. Epub 2023 May 12.
PubMed 37173409Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.
PubMed 31585051Sista AK, Miller LE, Kahn SR, Kline JA. Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis. Vasc Med. 2017 Feb;22(1):37-43. doi: 10.1177/1358863X16670250. Epub 2016 Oct 5.
PubMed 27707980Konstantinides SV, Barco S, Lankeit M, Meyer G. Management of Pulmonary Embolism: An Update. J Am Coll Cardiol. 2016 Mar 1;67(8):976-990. doi: 10.1016/j.jacc.2015.11.061.
PubMed 26916489Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
PubMed 31504429
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Use of Computer-Aided Vacuum Thrombectomy Within the Context of Intermediate and High-Risk Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT07650435
- Acronym / sponsor ID
- TiPE / 24RAD100
- Conditions
- Pulmonary Embolism and Thrombosis
- Keywords
- PE, Thrombectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 11 Dec 2029 (estimated)
- Study completion
- 11 Dec 2029 (estimated)
- First posted
- 16 Jun 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.
Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.
Detailed description
Acute intermediate-risk pulmonary embolism (PE) and high-risk PE can be life threatening. The incidence of PE is increasing , and patients who survive the acute presentation may experience significant morbidity including reduced exercise tolerance, and decreased quality of life (QoL). Often patients are treated with anticoagulation to stop the clot getting worse and encourage the body to slowly break up the clot. However in more severe cases thrombolysis medication can be given to actively break up the clot. Catheter directed thrombolysis can be used to target the lytic medication into the pulmonary arteries and reduced the systemic effects. Percutaneous thrombectomy is a newer treatment option that aspirates the clot, providing a faster and potentially lytic free solution to sick patients. Pulmonary artery thrombectomy (PAT) is a treatment option that is variably utilised and has unclear evidence base . The penumbra device uses a computer modulated vacuum aspiration system to both fatigue, breakup and aspirate the clot. This has been shown to be safe and effective in small cohorts. CAVT can prevent acute hemodynamic decompensation, alleviate acute PE-related symptoms, accelerate right ventricular recovery, and improve quality of life as measured by patient-reported outcomes (PROs). Despite existing literature addressing clinical outcomes with PE treatment, comprehensive data on PE-related morbidity, PROs and longer-term outcomes after mechanical thrombectomy are still lacking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAVT thrombectomy | – | –PE with evidence of right heart strain and thrombectomy with 16Fr CAVT |
| PE with evidence of right heart strain | – | –PE with evidence of right heart strain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PE <14 days and evidence of right heart strain
Key inclusion criteria (14 listed)
- Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
- Patients who present with computed tomography confirmed pulmonary embolism
- Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
- Date of computed tomography imaging from within a two-year period
- Patient is greater than or equal to 18 years of age
Key exclusion criteria (6 listed)
- Known serious, uncontrolled sensitivity to radiographic agents
- Computed tomography not available to evaluate pulmonary embolism
- Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
- Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
- Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LV/RV ratio
Time frame: 48 (+ 48 /- 24) hours post procedure.
1. To evaluate the effectiveness of PE CAVT as a treatment for intermediate and high-risk PE as measured by change pulmonary arterial pressure and in RV/LV (Right Ventricle to Left Ventricle diameter) ratio at 48 (+ 48 /- 24) hours post procedure.
Morbidity and mortality
Time frame: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Ascertain the mortality and morbidity profile for CAVT within intermediate and high-risk PE, within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
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 25 Jun 2026.
- Background11. National institute of Clinical Excellence. Pulmonary embolism: what are the risk factors. NICE guidelines. https://cks.nice.org.uk/topics/pulmonary-embolism/background-information/risk-factors/
- Background: PubMed 24694625Noble S, Lewis R, Whithers J, Lewis S, Bennett P. Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study. BMJ Open. 2014 Apr 2;4(4):e004561. doi: 10.1136/bmjopen-2013-004561.
- Background: PubMed 34247098Danielsbacka JS, Rostberg L, Olsen MF, Mannerkorpi K. "Whole life changed" - Experiences of how symptoms derived from acute pulmonary embolism affects life. A qualitative interview study. Thromb Res. 2021 Sep;205:56-62. doi: 10.1016/j.thromres.2021.07.004. Epub 2021 Jul 5.
- Background8. Perkowski, Paul et al Computer-aided Mechanical Aspiration Thrombectomy with the Indigo Lightning 12 Aspiration System for the Treatment of Acute Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.Journal of Vascular Surgery, Volume 77, Issue 4, 52S - 53S
- Background: PubMed 38729421Moriarty JM, Dohad SY, Schiro BJ, Tamaddon H, Heithaus RE, Iliadis EA, Dexter DJ 2nd, Shavelle DM, Leal SRN, Attallah AS, West FM, Keeling WB, Sharp ASP, Weinberg I. Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study. J Vasc Interv Radiol. 2024 Aug;35(8):1154-1165.e6. doi: 10.1016/j.jvir.2024.04.028. Epub 2024 May 9.
- Background: PubMed 34911082Mathews SJ. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration. Tex Heart Inst J. 2021 Nov 1;48(5):e217571. doi: 10.14503/THIJ-21-7571. No abstract available.
- Background: PubMed 37173409Gotzinger F, Lauder L, Sharp ASP, Lang IM, Rosenkranz S, Konstantinides S, Edelman ER, Bohm M, Jaber W, Mahfoud F. Interventional therapies for pulmonary embolism. Nat Rev Cardiol. 2023 Oct;20(10):670-684. doi: 10.1038/s41569-023-00876-0. Epub 2023 May 12.
- Background: PubMed 31585051Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.
- Background: PubMed 27707980Sista AK, Miller LE, Kahn SR, Kline JA. Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis. Vasc Med. 2017 Feb;22(1):37-43. doi: 10.1177/1358863X16670250. Epub 2016 Oct 5.
- Background: PubMed 26916489Konstantinides SV, Barco S, Lankeit M, Meyer G. Management of Pulmonary Embolism: An Update. J Am Coll Cardiol. 2016 Mar 1;67(8):976-990. doi: 10.1016/j.jacc.2015.11.061.
- Background: PubMed 31504429Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Individual participant dataSharing planned: Undecided. Requests for data sharing can be made after publication of the primary results paper. Requests should be made to the Chief Investigator in the first instance. Requesters will be asked to complete an application form detailing specific requirements, rationale, and proposed usage. The CI and study sponsor (including the sponsor's Research Governance Manager (or deputy), the Information Governance Team, Calidcott Guardian, IM\&T Security Officer and the researcher funder, as appropriate) will review all requests. Consideration will be given to: 1. The viability and suitability of the request 2. Appropriate steps have been taken to minimise the risk of identifying participants 3. Data security policies and procedures of recipient organisation (including country if abroad) and other regulatory requirements are applicable 4. The credentials of the requestor Where access to requested data is granted, requesters organisation must sign a data sharing agreement before they can access any data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Thrombosis, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Paul Jenkins (01752438000, plh-tr.tipe@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV/RV ratio (time frame: 48 (+ 48 /- 24) hours post procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07650435, which also lists 11 linked publications.
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 25 Jun 2026.