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NCT06297291 · ClinicalTrials.gov registry record

Global Paradise System US Post Approval Study

A clinical trial of Hypertension and Cardiovascular Diseases, sponsored by ReCor Medical.

Recruiting
Registry status
1,000
Enrollment target
20
Study locations

NCT06297291: Recruiting study of Hypertension and Cardiovascular Diseases, sponsored by ReCor Medical.

NCT06297291 is a study of Hypertension and Cardiovascular Diseases that is actively recruiting participants, run by ReCor Medical. The registered enrollment target is 1,000 participants, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06297291, a study of Hypertension and Cardiovascular Diseases, is actively recruiting participants, sponsored by ReCor Medical.

RECRUITING
Registry status
1,000 participants
Enrollment target
20
Study locations

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.

Primary Outcome

* Ho: Reduction in mean home systolic BP from baseline to 3 months \< 5 mmHg * Ha: Reduction in mean home systolic BP from baseline to 3 months ≥ 5 mmHg

Conditions Studied

Hypertension Cardiovascular Diseases Vascular Diseases

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
ReCor Medical

5 total trials

What NCT06297291 shows while recruiting

NCT06297291 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (71% lower).

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.

NCT06297291 names 20 study sites across 12 states, led by Florida, New York, California.

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.

What interventions are being tested in trial NCT06297291?

The interventions under investigation include: Paradise Ultrasound Renal Denervation Treatment (DEVICE).

Who is sponsoring clinical trial NCT06297291?

This trial is sponsored by ReCor Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06297291's enrollment target sits among peer trials

1,000 65th of 470 higher than 396 of 470 other Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06297291

Source: ClinicalTrials.gov NCT06297291, the US trial registry maintained by the National Library of Medicine. NCT06297291 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.