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Procedure

Symphony Thrombectomy system for Embolism

N/A

Recruiting

Research Sponsored by Imperative Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical signs and symptoms consistent with acute PE.

Subject is between 18 and 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

Study Summary

This trial studied using a device to treat PE and found it to be safe and effective.

Who is the study for?

This trial is for adults aged 18-80 with recent pulmonary embolism (PE), confirmed by CTA, who have symptoms of PE and a stable blood pressure and heart rate. Participants must have an enlarged right ventricle but be in a stable condition to give consent and follow the study protocol.Check my eligibility

What is being tested?

The Symphony Thrombectomy System is being tested for safety and effectiveness in removing blood clots from the lungs (pulmonary embolism). This device aims to improve cardiovascular health by treating these potentially life-threatening clots.See study design

What are the potential side effects?

While specific side effects are not listed, thrombectomy procedures can generally cause bleeding, bruising at the catheter site, infection risk, or rare complications like injury to the blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am showing signs of a possible pulmonary embolism.

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I am between 18 and 80 years old.

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My blood pressure is at least 90 mmHg and I have a heart condition where my right ventricle is enlarged.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean reduction of RV/LV ratio

Rate of major adverse events

Secondary outcome measures

Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury

Rates of PE related mortality, all-cause mortality, device-related SAEs and symptomatic PE recurrence

Trial Design

1Treatment groups

Experimental Treatment

Group I: Symphony Thrombectomy systemExperimental Treatment1 Intervention

Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Imperative Care, Inc.Lead Sponsor

1 Previous Clinical Trials

262 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment increasing for this research project?

"That is accurate. According to the information on clinicaltrials.gov, this medical experiment was initially posted on December 8th 2023 and requires 150 individuals from a single site for participation. It has been recently updated as of December 8th 2023 and presently seeks applicants."

Answered by AI

Does this investigation have any open slots for new participants?

"Affirmative. The information found on clinicaltrials.gov shows that this medical study, which was introduced to the public on December 8th 2023, is still actively recruiting patients. 150 individuals have been sought from a single site for participation in the trial."

Answered by AI

Is this research accessible to participants over the age of seventy?

"Contingent upon meeting the age range requirement of 18-80 years old, potential participants are welcome to apply. Additionally, there are 54 studies available for people younger than 18 and 760 research opportunities for those over 65."

Answered by AI

How can I become a participant in this trial?

"This clinical trial seeks 150 persons with cardiovascular disease, aged 18 to 80. To be eligible for this study, applicants must sign an IRB-approved informed consent form and present evidence of acute pulmonary embolism within the last 14 days in addition to other criteria. Moreover, subjects should have systolic blood pressure greater than 90mmHg supported by dilated right ventricle (RV/LV ratio >0.9) as assessed by investigators; heart rate lower than 130 beats per minute before procedure; and willingness and ability to comply with protocol follow-up requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SYMPHONY-PE Study for Treatment of Pulmonary Embolism

2023. "SYMPHONY-PE Study for Treatment of Pulmonary Embolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06062329.

All > Pulmonary Embolism