Status:
COMPLETED
SPYRAL DYSTAL Renal Denervation Global Clinical Study
Lead Sponsor:
Medtronic Vascular
Conditions:
Hypertension
Vascular Diseases
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure...
Eligibility Criteria
Inclusion
- \- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.
- Individual is willing to discontinue current antihypertensive medications
Exclusion
- Individual has estimated glomerular filtration rate (eGFR) of \<45.
- Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
- Individual has one or more episodes of orthostatic hypotension.
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to become pregnant.
- Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
- Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
- Individual works night shifts.
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04311086
Start Date
June 12 2020
End Date
December 22 2022
Last Update
April 17 2024
Active Locations (8)
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1
Stanford Hospital and Clinics
Stanford, California, United States, 94305
2
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
3
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226
4
Universitaetsklinikum Erlangen
Erlangen, Germany