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Device

Renal Denervation for High Blood Pressure

Q: Are there any vacancies available for individuals in this clinical experiment?

As per clinicaltrials.gov, this study is not actively looking for participants at the present time; however, it was first posted on July 1st 2015 and last updated October 21st 2022. Fortunately, there are 1188 other trials currently enrolling patients that could use your help.

Q: What are the criteria for qualifying to be part of this research endeavor?

This medical trial is accepting 337 participants between the ages of 20 and 80 who have been diagnosed with a vascular disease.

Q: How many medical facilities are participating in the experiment?

Currently, there are 29 participating sites scattered across the continent. These include Toronto, Hamilton and Portland as well as a slew of other locations. To ease any potential burden on participants, it's suggested that they find the closest trial centre to their home address.

Q: Are the elderly being incorporated into this research project?

The study seeks participants that are between 20 to 80 years of age. However, there are 82 trials for minors and 1,055 trials open to seniors available on the same platform.

N/A

Waitlist Available

Led By Raymond Townsend, 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 has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Awards & highlights

Study Summary

This trial is testing whether a kidney surgery can lower blood pressure when done alongside other blood pressure medications.

Who is the study for?

This trial is for adults with high blood pressure (140-170 mmHg over 24 hours, or office SBP of 150-180 mmHg and DBP ≥ 90 mmHg) while on up to three blood pressure medications. It's not for those with severe kidney issues, recent heart problems, certain vascular conditions, poor renal anatomy, chronic pain treated with NSAIDs often, pregnant/nursing women, uncontrolled diabetes, orthostatic hypotension or night shift workers.Check my eligibility

What is being tested?

The SPYRAL HTN-ON MED Study is testing if the Symplicity Spyral™ renal denervation system can safely lower blood pressure compared to a sham procedure in patients already taking up to three antihypertensive drugs.See study design

What are the potential side effects?

Potential side effects may include reactions related to the catheter-based procedure such as bleeding or bruising at the access site, damage to the kidney arteries or nerves around them; however specific risks will be detailed by study staff.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood pressure is high even though I am on 1-3 blood pressure medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 1 month post-procedure (6 months for new renal artery stenosis)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1 month post-procedure (6 months for new renal artery stenosis) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events

Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Secondary outcome measures

Antihypertensive Medication Burden to 6-months

Antihypertensive Medication Usage and Changes to 6-months

Change in Office Systolic Blood Pressure

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Renal DenervationExperimental Treatment1 Intervention

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Group II: Sham ProcedurePlacebo Group1 Intervention

Renal angiography

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Symplicity Spyral™ multi-electrode renal denervation system

2015

N/A

~370

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic VascularLead Sponsor

65 Previous Clinical Trials

55,925 Total Patients Enrolled

Raymond Townsend, MDPrincipal InvestigatorUniversity of Pennsylvania

3 Previous Clinical Trials

457 Total Patients Enrolled

David Kandzari, MDPrincipal InvestigatorPiedmont Hospital

17 Previous Clinical Trials

8,006 Total Patients Enrolled

Media Library

Symplicity Spyral™ multi-electrode renal denervation system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02439775 — N/A

High Blood Pressure Research Study Groups: Renal Denervation, Sham Procedure

High Blood Pressure Clinical Trial 2023: Symplicity Spyral™ multi-electrode renal denervation system Highlights & Side Effects. Trial Name: NCT02439775 — N/A

Symplicity Spyral™ multi-electrode renal denervation system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02439775 — N/A

High Blood Pressure Patient Testimony for trial: Trial Name: NCT02439775 — N/A

Frequently Asked Questions

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

Are there any vacancies available for individuals in this clinical experiment?

"As per clinicaltrials.gov, this study is not actively looking for participants at the present time; however, it was first posted on July 1st 2015 and last updated October 21st 2022. Fortunately, there are 1188 other trials currently enrolling patients that could use your help."

Answered by AI

What are the criteria for qualifying to be part of this research endeavor?

"This medical trial is accepting 337 participants between the ages of 20 and 80 who have been diagnosed with a vascular disease."

Answered by AI

How many medical facilities are participating in the experiment?

"Currently, there are 29 participating sites scattered across the continent. These include Toronto, Hamilton and Portland as well as a slew of other locations. To ease any potential burden on participants, it's suggested that they find the closest trial centre to their home address."

Answered by AI

Are the elderly being incorporated into this research project?

"The study seeks participants that are between 20 to 80 years of age. However, there are 82 trials for minors and 1,055 trials open to seniors available on the same platform."

Answered by AI