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Device
Renal Denervation for High Blood Pressure
N/A
Recruiting
Led By David Kandzari, MD
Research Sponsored by Medtronic Vascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
Diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Awards & highlights
Study Summary
This trial will study the long-term effects of a treatment for high blood pressure.
Who is the study for?
This trial is for individuals with high blood pressure (systolic ≥140 mmHg) who may also have diabetes, kidney disease, or cardiovascular issues. It's not suitable for those with severe kidney impairment (eGFR <30), pregnant women, or anyone lacking the right renal artery anatomy.Check my eligibility
What is being tested?
The study tests the Symplicity Spyral system's safety and effectiveness in lowering blood pressure through renal denervation—a procedure that disrupts nerve signals to the kidneys.See study design
What are the potential side effects?
While specific side effects are not listed here, renal denervation procedures can potentially cause nerve damage, bleeding, infection, or negative reactions related to catheter-based treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure with a reading of 140 mmHg or higher.
Select...
I have high blood pressure with a reading of 140 mmHg or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
Secondary outcome measures
Change from baseline in EQ-5D quality of life score
Change from baseline in hypertension health status score
Change in blood pressure as measured by 24-hour ABPM
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Main Cohort: Renal DenervationExperimental Treatment1 Intervention
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Denervation (Symplicity Spyral™)
2020
N/A
~130
Find a Location
Who is running the clinical trial?
Medtronic VascularLead Sponsor
65 Previous Clinical Trials
54,862 Total Patients Enrolled
David Kandzari, MDPrincipal InvestigatorPiedmont Heart Institute
17 Previous Clinical Trials
6,943 Total Patients Enrolled
Felix Mahfoud, MDPrincipal InvestigatorSaarland University Hospital
6 Previous Clinical Trials
2,729 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney arteries are not suitable for the procedure.You have a medical condition that makes it hard to get an accurate blood pressure reading.I need oxygen or a ventilator daily, not just for sleep apnea at night.I have high blood pressure with a reading of 140 mmHg or higher.Your kidney function, measured by eGFR, is very low.I have high blood pressure in the lungs.I have had a procedure to decrease nerve activity in my kidneys.I have high blood pressure with a reading of 140 mmHg or higher.I have experienced dizziness due to a sudden drop in blood pressure when standing up.
Research Study Groups:
This trial has the following groups:- Group 1: Main Cohort: Renal Denervation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Kidney Disease Patient Testimony for trial: Trial Name: NCT05198674 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are able to join this clinical trial?
"Medtronic Vascular, the sponsor of this research project, requires 1,200 participants who meet their criteria to run the trial. The study will be managed from Baylor Jack and Jane Hamilton Heart and Vascular Hospital in Dallas, Texas and Morristown Medical Center in New jersey."
Answered by AI
Is recruitment for participation in this research still open?
"This investigation, posted originally on October 20th 2021 and recently modified on November 29th 2022 is currently recruiting participants according to the information available at clinicaltrials.gov."
Answered by AI
Are there any Canadian locations where this investigation is being conducted?
"This clinical trial has 6 enrolment sites, including Baylor Jack and Jane Hamilton Heart and Vascular Hospital in Dallas, Morristown Medical Center in Morristown, and the Heart Care Centers of Illinois. The other three locations can be found on clinicialtrials.gov"
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
Piedmont Heart Institute
Ascension Providence Hospital
HonorHealth Research Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
To adress my medical condition. I want to find a solution to my high BP. My blood pressure is just getting higher and higher it seems like.
PatientReceived 2+ prior treatments
Need to try something different and improve my sugars willing to do anything.
PatientReceived no prior treatments
I have tried 2 different drugs and my blood pressure is still extremely high?
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the screening process?
PatientReceived 2+ prior treatments
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