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Device

Renal Denervation (Symplicity Spyral™) for High Blood Pressure

N/A

Waitlist Available

Led By David P Lee, MD

Research Sponsored by Medtronic Vascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 months post-procedure

Awards & highlights

Study Summary

This trial is testing if a simpler form of a blood pressure treatment is just as effective as a more complex treatment.

Eligible Conditions

High Blood Pressure
Cardiovascular Disease
Vascular Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in systolic blood pressure (SBP) from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Secondary outcome measures

Acute and chronic safety by evaluating incidence of Major Adverse Events

Change in office diastolic blood pressure

Change in office diastolic blood pressure baseline as measured by 24-hour ABPM

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 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

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Who is running the clinical trial?

Medtronic VascularLead Sponsor

65 Previous Clinical Trials

56,134 Total Patients Enrolled

David P Lee, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

4,199 Total Patients Enrolled

Andrew Sharp, MDPrincipal InvestigatorUniversity Hospital of Wales

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program accept participants who are over 30 years old?

"This medical trial is looking for participants aged between 20 and 80 years."

Answered by AI

What category of individuals can take part in this clinical study?

"This research requires the enrolment of 56 individuals aged between 20 and 80 with cardiovascular diseases who are willing to cease taking any existing antihypertensive medications."

Answered by AI

Is enrollment open at present for this research project?

"Clinicaltrials.gov indicates that this medical experiment is not enrolling patients at this time, despite its initial posting on June 12th 2020 and most recent update from October 21st 2022. However, there are still 1,192 other clinical trials actively looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SPYRAL DYSTAL Renal Denervation Global Clinical Study

2020. "SPYRAL DYSTAL Renal Denervation Global Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04311086.