Pulmonary EmbolismSONIC-PENCT06310018
Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE
An observational study of Pulmonary Embolism and Right Ventricular Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Right Ventricular Dysfunction, Right Ventricular Failure
- What is being tested?
- Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis and Tissue Plasminogen Activator
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2028
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who present for evaluation and treatment of PE and in whom the decision to proceed with the EKOS+™ ultrasound-facilitated, catheter-directed lower-dose fibrinolytic procedure will be screened for inclusion in the study.
Who may be able to join
- patients at least 18 years of age,
- symptomatic PE defined as symptoms for <14 days with normal systolic blood pressure (>90 mmHg), RV-to-LV diameter ratio ≥0.9 on initial chest CT, bilateral filling defects located in at least 1 main or proximal lobar pulmonary artery, and cardiac troponin greater than the upper limit of normal (cTnI, cTnT, hsTnI, or hsTnT), AND
- in whom ultrasound-facilitated, catheter-directed lower-dose fibrinolysis has been selected for treatment on a clinical basis.
Who cannot join
- stroke or transient ischemic attack, head trauma, other active intracranial or intraspinal disease (including malignancy) within 1 year
- recent active bleeding from a major organ within 1 month
- major surgery within 7 days of screening
- contraindication to therapeutic anticoagulation
- systolic blood pressure <90 mm Hg, systolic blood pressure drop by at least 40 mmHg over at least 15 minutes, shock, use of vasopressors, need for CPR, or need for ECMO
- need for mechanical ventilation, including non-invasive positive pressure ventilation
Show all 15Show fewer
- hematocrit <30%, platelet count <100,000/μl
- international normalized ratio >3
- serum creatinine > 2 mg/dL
- liver cirrhosis
- known hypersensitivity to tPA, heparin, or any excipients
- perceived high risk for fatal or catastrophic bleeding
- prescription of dual antiplatelet therapy (DAPT) at time of screening
- Patients treated with any other advanced therapy, such as surgical embolectomy, catheter-based mechanical embolectomy, or fibrinolytic therapy, within the prior 30 days
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Prospective, Single-Arm, Multicenter Study of Augmented Ultrasound-Facilitated, Catheter-Directed Low-Dose Fibrinolysis for Pulmonary Embolism (SONIC-PE)
SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding.
Read the detailed description
Patients with intermediate-high risk pulmonary embolism (PE) comprise a population at increased risk for clinical deterioration despite initially stable hemodynamics. The pathophysiology of hemodynamic deterioration in intermediate-high risk PE includes an abrupt increase in pulmonary vascular resistance, due to proximal as well as distal pulmonary artery occlusion, pulmonary hypertension, right ventricular (RV) pressure overload, and, ultimately, RV failure. While full-dose systemic fibrinolysis for PE has demonstrated efficacy for prevention of early morbidity and mortality, its net clinical benefit is attenuated by the risk of major bleeding, in particular intracranial hemorrhage. Catheter-directed therapies have been demonstrated to facilitate RV recovery while reducing the risk of major bleeding through use of lower-dose fibrinolysis or avoiding it altogether. Specifically, lower-dose regimens for ultrasound-facilitated, catheter-directed fibrinolysis result in sustained recovery of echocardiographically-determined RV function, reduction in Modified Miller Score (large-vessel pulmonary angiographic obstruction), functional status, and quality of life over the year following ultrasound-facilitated, catheter-directed fibrinolysis.
Recently, an upgrade to the output of the ultrasonic core catheter of the EKOS™ Endovascular System (EKOS+™) has demonstrated the ability to enhance fibrinolysis within a lower fibrinolytic dose range in preliminary studies (Boston Scientific Corporation, Maple Grove, MN). Compared with current EkoSonic™ system, a 50% increase in ultrasound power (measured in watts) with EKOS+™ resulted in a 130% increase in in vitro clot lysis compared with conventional catheter-directed fibrinolysis using the same dose of fibrinolytic drug.
SONIC-PE is multicenter, prospective single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding. The study will have an adaptive design component with transition to 8 mg tPA/2 hours if there is an excess of bleeding or observed lack of efficacy, as determined by an Independent Study Safety Monitor.
- Being tested
- Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis, Tissue Plasminogen Activator
- Keywords
- pulmonary embolism, right ventricular failure, right ventricular dysfunction, catheter-directed therapy, fibrinolysis
- Medical subject headings
- Pulmonary Embolism, Ventricular Dysfunction, Right, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-facilitated, catheter-directed lower-dose fibrinolysisDevice
Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (treated with a total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours for first 10 patients followed by 50 patients treated with total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system
Tissue Plasminogen ActivatorDrug
total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours for first 10 patients followed by 50 patients treated with total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis | 10 patients with bilateral PE will be treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system Receives: Device: Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis; Drug: Tissue Plasminogen Activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours
Change in RV-to-LV ratio will be determined by a dedicated core imaging laboratory, blinded to clinical data and timing of the CT studies
Measured: 48 ± 6 hours
Frequency of ISTH major bleeding at 72 hours
Adjudicated independently using ISTH criteria
Measured: 72 hours
Secondary outcomes (2)
Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours
Baseline and 48 ± 6 hours CT scans will be analyzed offline using 3D volumetric analysis
Measured: 48 ± 6 hours
Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours
Determined by a dedicated core imaging laboratory, blinded to clinical data and timing of the CT studies. Scores range from 0-40 with 0 meaning no obstruction.
Measured: 48 ± 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Awaiting completion and reporting of related trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
- Investigators
- Gregory Piazza, MD, MS, Principal investigator, BWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310018
- Sponsor's protocol ID
- 2023A070902
- Acronym
- SONIC-PE
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Will consider requests of scientific merit
Publications
Konstantinides 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 31504429Hassan SM, Nardelli P, Minhas JK, Ash SY, Estepar RSJ, Antkowiak MC, Badlam JB, Piazza G, Estepar RSJ, Washko GR, Rahaghi FN. CT imaging determinants of persistent hypoxemia in acute intermediate-risk pulmonary embolism. J Thromb Thrombolysis. 2023 Jul;56(1):196-201. doi: 10.1007/s11239-023-02813-x. Epub 2023 May 4.
PubMed 37140805Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.
PubMed 35588898Piazza G. Advanced Management of Intermediate- and High-Risk Pulmonary Embolism: JACC Focus Seminar. J Am Coll Cardiol. 2020 Nov 3;76(18):2117-2127. doi: 10.1016/j.jacc.2020.05.028.
PubMed 33121720Rahaghi FN, San Jose Estepar R, Goldhaber SZ, Minhas JK, Nardelli P, Vegas Sanchez-Ferrero G, De La Bruere I, Hassan SM, Mason S, Ash SY, Come CE, Washko GR, Piazza G. Quantification and Significance of Pulmonary Vascular Volume in Predicting Response to Ultrasound-Facilitated, Catheter-Directed Fibrinolysis in Acute Pulmonary Embolism (SEATTLE-3D). Circ Cardiovasc Imaging. 2019 Dec;12(12):e009903. doi: 10.1161/CIRCIMAGING.119.009903. Epub 2019 Dec 17. No abstract available.
PubMed 31842589
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multicenter Study of Augmented Ultrasound-Facilitated, Catheter-Directed Low-Dose Fibrinolysis for Pulmonary Embolism (SONIC-PE)
- ClinicalTrials.gov ID
- NCT06310018
- Acronym / sponsor ID
- SONIC-PE / 2023A070902
- Keywords
- pulmonary embolism, right ventricular failure, right ventricular dysfunction, catheter-directed therapy, fibrinolysis
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Awaiting completion and reporting of related trial
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Mar 2024 (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.
SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding.
Detailed description
Patients with intermediate-high risk pulmonary embolism (PE) comprise a population at increased risk for clinical deterioration despite initially stable hemodynamics. The pathophysiology of hemodynamic deterioration in intermediate-high risk PE includes an abrupt increase in pulmonary vascular resistance, due to proximal as well as distal pulmonary artery occlusion, pulmonary hypertension, right ventricular (RV) pressure overload, and, ultimately, RV failure. While full-dose systemic fibrinolysis for PE has demonstrated efficacy for prevention of early morbidity and mortality, its net clinical benefit is attenuated by the risk of major bleeding, in particular intracranial hemorrhage. Catheter-directed therapies have been demonstrated to facilitate RV recovery while reducing the risk of major bleeding through use of lower-dose fibrinolysis or avoiding it altogether. Specifically, lower-dose regimens for ultrasound-facilitated, catheter-directed fibrinolysis result in sustained recovery of echocardiographically-determined RV function, reduction in Modified Miller Score (large-vessel pulmonary angiographic obstruction), functional status, and quality of life over the year following ultrasound-facilitated, catheter-directed fibrinolysis.
Recently, an upgrade to the output of the ultrasonic core catheter of the EKOS™ Endovascular System (EKOS+™) has demonstrated the ability to enhance fibrinolysis within a lower fibrinolytic dose range in preliminary studies (Boston Scientific Corporation, Maple Grove, MN). Compared with current EkoSonic™ system, a 50% increase in ultrasound power (measured in watts) with EKOS+™ resulted in a 130% increase in in vitro clot lysis compared with conventional catheter-directed fibrinolysis using the same dose of fibrinolytic drug.
SONIC-PE is multicenter, prospective single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding. The study will have an adaptive design component with transition to 8 mg tPA/2 hours if there is an excess of bleeding or observed lack of efficacy, as determined by an Independent Study Safety Monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis | – | Device: Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis, Drug: Tissue Plasminogen Activator10 patients with bilateral PE will be treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present for evaluation and treatment of PE and in whom the decision to proceed with the EKOS+™ ultrasound-facilitated, catheter-directed lower-dose fibrinolytic procedure will be screened for inclusion in the study.
Key inclusion criteria (3 listed)
- patients at least 18 years of age,
- symptomatic PE defined as symptoms for <14 days with normal systolic blood pressure (>90 mmHg), RV-to-LV diameter ratio ≥0.9 on initial chest CT, bilateral filling defects located in at least 1 main or proximal lobar pulmonary artery, and cardiac troponin greater than the upper limit of normal (cTnI, cTnT, hsTnI, or hsTnT), AND
- in whom ultrasound-facilitated, catheter-directed lower-dose fibrinolysis has been selected for treatment on a clinical basis.
Key exclusion criteria (15 listed)
- stroke or transient ischemic attack, head trauma, other active intracranial or intraspinal disease (including malignancy) within 1 year
- recent active bleeding from a major organ within 1 month
- major surgery within 7 days of screening
- contraindication to therapeutic anticoagulation
- systolic blood pressure <90 mm Hg, systolic blood pressure drop by at least 40 mmHg over at least 15 minutes, shock, use of vasopressors, need for CPR, or need for ECMO
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 |
|---|---|---|
| Ultrasound-facilitated, catheter-directed lower-dose fibrinolysisUltrasound-facilitated, catheter-directed lower-dose fibrinolysis (treated with a total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours for first 10 patients followed by 50 patients treated with total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system | Device | Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis |
| Tissue Plasminogen Activatortotal dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours for first 10 patients followed by 50 patients treated with total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour | Drug | Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis |
Primary outcome
Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours
Time frame: 48 ± 6 hours
Change in RV-to-LV ratio will be determined by a dedicated core imaging laboratory, blinded to clinical data and timing of the CT studies
Frequency of ISTH major bleeding at 72 hours
Time frame: 72 hours
Adjudicated independently using ISTH criteria
2 secondary outcomes
Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours
Time frame: 48 ± 6 hours
Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours
Time frame: 48 ± 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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.
- Background: PubMed 37140805Hassan SM, Nardelli P, Minhas JK, Ash SY, Estepar RSJ, Antkowiak MC, Badlam JB, Piazza G, Estepar RSJ, Washko GR, Rahaghi FN. CT imaging determinants of persistent hypoxemia in acute intermediate-risk pulmonary embolism. J Thromb Thrombolysis. 2023 Jul;56(1):196-201. doi: 10.1007/s11239-023-02813-x. Epub 2023 May 4.
- Background: PubMed 35588898Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.
- Background: PubMed 33121720Piazza G. Advanced Management of Intermediate- and High-Risk Pulmonary Embolism: JACC Focus Seminar. J Am Coll Cardiol. 2020 Nov 3;76(18):2117-2127. doi: 10.1016/j.jacc.2020.05.028.
- Background: PubMed 31842589Rahaghi FN, San Jose Estepar R, Goldhaber SZ, Minhas JK, Nardelli P, Vegas Sanchez-Ferrero G, De La Bruere I, Hassan SM, Mason S, Ash SY, Come CE, Washko GR, Piazza G. Quantification and Significance of Pulmonary Vascular Volume in Predicting Response to Ultrasound-Facilitated, Catheter-Directed Fibrinolysis in Acute Pulmonary Embolism (SEATTLE-3D). Circ Cardiovasc Imaging. 2019 Dec;12(12):e009903. doi: 10.1161/CIRCIMAGING.119.009903. Epub 2019 Dec 17. No abstract available.
- Individual participant dataSharing planned: Undecided. Will consider requests of scientific merit
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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. This study is not recruiting at the moment.
Gregory Piazza, MD, MS principal investigator
BWH
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 Right Ventricular Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
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 3 inclusion and 15 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: paused, as of the sponsor's last update on 21 Jan 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours (time frame: 48 ± 6 hours). 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 NCT06310018, which also lists 5 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 21 Jan 2026.