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NCT05198674 · ClinicalTrials.gov registry record · NA
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
A NA study of Hypertension and Cardiovascular Diseases, sponsored by Medtronic Vascular.
- Active
- Registry status
- NA
- Development phase
- 1,300
- Enrollment target
- 20
- Study locations
NCT05198674: Active NA study of Hypertension and Cardiovascular Diseases, sponsored by Medtronic Vascular.
NCT05198674 is a NA study of Hypertension and Cardiovascular Diseases that is active but no longer recruiting, run by Medtronic Vascular. The registered enrollment target is 1,300 participants, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05198674, a NA study of Hypertension and Cardiovascular Diseases, is active but no longer recruiting, sponsored by Medtronic Vascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.
Primary Outcome
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort
Conditions Studied
Interventions
- DEVICE Renal Denervation (Symplicity Spyral™)
Study Locations (20)
Florida
- BayCare Health System - Clearwater
- Clearwater Cardiovascular Consultants - Clearwater
- Baptist Medical Center - Jacksonville
- University of Miami Hosptial - Miami
- AdventHealth Orlando - Orlando
- Orlando Health Heart & Vascular Institute - Orlando
- BayCare Medical Group - Safety Harbor
- Tallahassee Memorial Healthcare, Inc - Tallahassee
Arizona
- Banner Heart Hospital - Mesa
- Abrazo Arizona Heart Hospital/Biltmore Cardiology - Phoenix
- HonorHealth Research Institute - Scottsdale
California
- Scripps Memorial Hospital - La Jolla
- University of California, San Francisco - San Francisco
- Stanford Hospital and Clinics - Stanford
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- Colorado Heart and Vascular PC - Lakewood
Alabama
- University of Alabama at Birmingham (UAB) Hospital - Birmingham
Arkansas
- Arkansas Cardiology - Little Rock
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2029-11-30 |
| Phase | NA |
What the registry record for NCT05198674 still lists
NCT05198674 is an interventional study that assigns participants to a tested intervention. Its 1,300 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 (63% lower).
The record links to 5 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Renal Denervation (Symplicity Spyral™) is the first listed.
NCT05198674 names 20 study sites across 8 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05198674 about?
NCT05198674 is a clinical study titled "SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN". The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in th...
What is the current status of trial NCT05198674?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,300 participants. The study started on 2021-10-20. Estimated completion is 2029-11-30.
What conditions does trial NCT05198674 study?
This clinical trial studies the following conditions: Hypertension, Cardiovascular Diseases, Diabetes Mellitus, Chronic Kidney Diseases, Vascular Diseases.
What interventions are being tested in trial NCT05198674?
The interventions under investigation include: Renal Denervation (Symplicity Spyral™) (DEVICE).
Who is sponsoring clinical trial NCT05198674?
This trial is sponsored by Medtronic Vascular, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05198674 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05198674's enrollment target sits among peer trials
1,300 52nd of 470 higher than 418 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.
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