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New treatment option for Hypertension
Official title Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
ClinicalTrials.gov ID: NCT07115953
What this study is testing
- What it's testing
- 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 hypertensive population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
- Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline
You likely can't join if
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2
- Individual has one or more episode(s) of orthostatic hypotension
See the full eligibility criteria
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
- Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
- Individual has documented primary pulmonary hypertension
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Australia
- Perth, Australia
- Genk, Limburg, Belgium
- Liège, Liège, Belgium
- Aalst, Belgium
- Bruges, Belgium
- Ghent, Belgium
- Homburg, Saarland, Germany
- Lübeck, Schleswig-Holstein, Germany
- Erlangen, Germany
- Leipzig, Germany
- Villingen-Schwenningen, Germany
- Athens, Greece
- Dublin, Dublin, Ireland
- Kota, Malaysia
- Kuala Lumpur, Malaysia
- Heerlen, Netherlands
- Rotterdam, Netherlands
- Taipei, Taiwan
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Australia; Perth, Australia; Genk, Limburg, Belgium; Liège, Liège, Belgium; Aalst, Belgium; Bruges, Belgium and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.