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RECRUITING NA

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

NCT05650541 · View on ClinicalTrials.gov ↗

Study Summary

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the Sensinel CPM system against those who are not. This can either be done using institutions' averages, if available, or through a control group.

Conditions Studied

Interventions

  • DEVICE CardioPumlonary Management System

Study Locations (7)

Florida

  • Baptist Health South Florida — Miami
  • Orlando Health — Orlando

California

  • Desert Oasis Healthcare — Palm Springs

Massachusetts

  • Baystate Medical Center — Springfield

Nebraska

  • University of Nebraska Medical Center — Omaha

North Carolina

  • Cone Health — Greensboro

South Carolina

  • Prisma Health — Greenville

Trial Details

FieldValue
Enrollment Target 1,200 participants
Start Date 2023-09-22
Est. Completion 2026-06-01
Phase NA

Sponsor

Analog Device

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05650541

The ClinicalTrials.gov registry entry for NCT05650541 describes a study currently listed as recruiting. It is categorized as NA, 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 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Analog Device, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which CardioPumlonary Management System 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: NCT05650541 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Massachusetts. 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 NCT05650541 about?

NCT05650541 is a clinical study titled "Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure". The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the prim...

What is the current status of trial NCT05650541?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,200 participants. The study started on 2023-09-22. Estimated completion is 2026-06-01.

What conditions does trial NCT05650541 study?

This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05650541?

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

Who is sponsoring clinical trial NCT05650541?

This trial is sponsored by Analog Device, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05650541 being conducted?

This trial has 7 study locations across California, Florida, Massachusetts, Nebraska, North Carolina. 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