Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
19 participants
INTERVENTIONAL
2025-06-09
2027-07-01
Brief Summary
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Detailed Description
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There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows:
* To assess safety of RNS when performed prior to and post RDN.
* To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Renal nerve stimulation performed prior to and post renal artery denervation (RDN)
Renal nerve stimulation
Renal nerve stimulation will be performed prior to and post renal denervation.
Interventions
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Renal nerve stimulation
Renal nerve stimulation will be performed prior to and post renal denervation.
Eligibility Criteria
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Inclusion Criteria
2. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
3. Individual is prescribed with one, two, or three antihypertensive medication classes
4. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline
Exclusion Criteria
2. Individual lacks appropriate renal artery Anatomy
3. Has a renal artery stent
4. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
5. Individual is taking SGLT2 inhibitors or GLP-1 agonists
6. Individual requires chronic oxygen support or mechanical ventilation
7. Primary pulmonary hypertension.
8. Secondary cause of hypertension
9. Pregnant, nursing or planning to become pregnant during the study.
10. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
11. Individual is currently taking anti-mineralocorticoid drugs.
20 Years
70 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Locations
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University Hospital Galway
Galway, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDT24037
Identifier Type: -
Identifier Source: org_study_id
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