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COMPLETED Phase 2

Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

NCT03243942 · View on ClinicalTrials.gov ↗

Study Summary

The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired intracardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.

Interventions

  • DRUG Definity

Study Locations (1)

Pennsylvania

  • Thomas Jefferson University and Thomas Jefferson University Hospital — Philadelphia

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2017-06-01
Est. Completion 2019-06-26
Phase Phase 2

Sponsor

Thomas Jefferson University

324 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03243942

The ClinicalTrials.gov registry entry for NCT03243942 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 324 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Definity is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03243942 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03243942 about?

NCT03243942 is a clinical study titled "Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement". The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to asses...

What is the current status of trial NCT03243942?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2017-06-01. Estimated completion is 2019-06-26.

What conditions does trial NCT03243942 study?

This clinical trial studies the following conditions: Heart Failure, Blood Pressure, Cardiac Catheterization, Echocardiography, Heart Ventricles. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03243942?

The interventions under investigation include: Definity (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03243942?

This trial is sponsored by Thomas Jefferson University, which has 324 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03243942 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial