This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.
For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site. For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.
Study Type
OBSERVATIONAL
Enrollment
1,480
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)
Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy).
Time frame: Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.
Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.
Time frame: Post-procedure hospitalization through hospital discharge up to 14 days
Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.
Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.
Time frame: From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.
Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.
Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events.
Time frame: From time of APT procedure through 12 months post-procedure.
All-cause Mortality During First 12 Months Post-procedure.
Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.
Time frame: Start of procedure through 12 months post-procedure.
Healthcare Utilization
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Healthfinity, PLLC Advanced Cardiac & Vascular Clinic
Glendale, Arizona, United States
Cedars - Sinai
Los Angeles, California, United States
Radiology Imaging Associates
Englewood, Colorado, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
St. Vincent's Healthcare
Jacksonville, Florida, United States
University of Florida
Jacksonville, Florida, United States
Memorial Hospital
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
...and 70 more locations
Summary of healthcare utilization from date of enrollment through discharge.
Time frame: Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).
Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits
Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome.
Time frame: Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.
Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits.
Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome.
Time frame: Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.
Number of Patients Needing an IVC Filter Placement
Measured by number patients with an occurrence of needing an IVC filter placement.
Time frame: From date of procedure through 12 months
Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity
Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe).
Time frame: From post-procedure through 12-months post-procedure
Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.
Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.
Time frame: From post-procedure through 12-months post-procedure
Diagnosis of Pulmonary Hypertension Diagnosis
New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE.
Time frame: Analyzed 12 months post-procedure