Renal Denervation for Uncontrolled Hypertension
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Recruiting
N/A
Interventional Study
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- Medtronic Vascular · Industry
Who this trial is looking for
This trial is looking for adults with high blood pressure that is not controlled with medication. Participants will undergo a procedure using a specific system designed to reduce blood pressure.
Are You a Good Fit for This Trial?
You may be able to join if
- I have high blood pressure with a systolic number of 140 or higher.
- I have a diastolic blood pressure of 90 or higher.
- My average home blood pressure is 135 or higher.
- I have a valid 24-hour blood pressure measurement.
You may not be able to join if
- I do not have suitable renal artery anatomy.
- I have had renal denervation before.
- I have a condition that makes it hard to measure my blood pressure accurately.
- I need chronic oxygen support or mechanical ventilation.
- My kidney function is low (eGFR less than 45).
- I have had episodes of low blood pressure when standing up.
- I am pregnant, nursing, or planning to become pregnant.
- I have primary pulmonary hypertension.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertens…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
3. Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre…
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