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RECRUITING

Global Paradise System US Post Approval Study

NCT06297291 · View on ClinicalTrials.gov ↗

Study Summary

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.

Interventions

  • DEVICE Paradise Ultrasound Renal Denervation Treatment

Study Locations (20)

Florida

  • The Cardiac & Vascular Institute — Gainesville
  • University of Miami Health System — Miami
  • Ascension Sacred Heart — Pensacola
  • Tampa Cardiovascular Interventions and Research — Tampa

New York

  • Albany Medical Center — Albany
  • University at Buffalo — Buffalo
  • NYU Langone Health - Bellevue Hosptial — New York
  • Columbia University Medical Center/New York Presbyterian Hospital — New York

California

  • Sutter Institute for Medical Research — Sacramento
  • UC Davis Medical Center — Sacramento

Massachusetts

  • Massachusetts General Hospital — Boston
  • The Brigham and Women's Hospital — Boston

Colorado

  • Rocky Mountain Regional VAMC — Aurora

Connecticut

  • Bridgeport Hosptial — Bridgeport

Illinois

  • Southern Illinois University, Memorial Medical Center — Springfield

Kansas

  • Ascension via Christi St. Francis — Wichita

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2024-06-28
Est. Completion 2031-07

Sponsor

ReCor Medical

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06297291

The ClinicalTrials.gov registry entry for NCT06297291 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ReCor Medical, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention — of which Paradise Ultrasound Renal Denervation Treatment 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: NCT06297291 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, California. 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 NCT06297291 about?

NCT06297291 is a clinical study titled "Global Paradise System US Post Approval Study". The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a ...

What is the current status of trial NCT06297291?

This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2024-06-28. Estimated completion is 2031-07.

What conditions does trial NCT06297291 study?

This clinical trial studies the following conditions: Hypertension, Cardiovascular Diseases, Vascular Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06297291?

The interventions under investigation include: Paradise Ultrasound Renal Denervation Treatment (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06297291?

This trial is sponsored by ReCor Medical, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06297291 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. 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