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 as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Stanford Hospital and Clinics
Stanford, California, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Universitaetsklinikum Erlangen
Erlangen, Germany
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 12 months post-procedure
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 3 months post-procedure
Change in Office Systolic Blood Pressure (SBP)
Time frame: From Baseline (SV2) to 3 months post-procedure
Change in Office Systolic Blood Pressure (SBP)
Time frame: From Baseline (SV2) to 12 months post-procedure
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 3 months post-procedure
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 12 months post-procedure
Change in Office Diastolic Blood Pressure (DBP)
Time frame: From Baseline (SV2) to 3 month post-procedure
Change in Office Diastolic Blood Pressure (DBP)
Time frame: From Baseline (SV2) to 12 months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Time frame: 3 months post-procedure
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Universitaetsklinikum des Saarlandes
Homburg, Germany
Herzzentrum Leipzig
Leipzig, Germany
Hippokration General Hospital of Athens
Athens, Greece
University Hospital of Wales
Cardiff, United Kingdom
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Time frame: 12 months post-procedure
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Incidence of the following events: * All-cause mortality * End-stage renal disease (ESRD) * Significant embolic event resulting in end-organ damage * Renal artery perforation requiring intervention * Renal artery dissection requiring intervention * Vascular complications * Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol * New renal artery stenosis \>70%, confirmed by angiography and as determined by the angiographic core lab at 6 months follow up
Time frame: From Baseline (SV2) to 12 months post-procedure
Incidence of Myocardial Infarction
Defined as the concurrent documentation of two of the three elements listed below in the appropriate clinical circumstance: 1. Chest pain or ischemic equivalent 2. New pathologic q waves in at least 2 contiguous ECG leads 3. Cardiac biomarker elevation by any of the definitions below: Appropriate cardiac enzyme data (respecting top-down hierarchy): 1. CK greater than or equal to 2\* URL confirmed by: * CKMB \> l\*URL or * in the absence of CKMB: Troponin \> l\*URL or 2. in the absence of CK: * CKMB \> 3\*URL * In the absence of CK and CKMB: Troponin \> 3\*URL * In the absence of CK, CKMB and Troponin, clinical decision based upon clinical scenario
Time frame: From baseline (SV2) to 12 months post-procedure
Incidence of Stroke
Time frame: From baseline (SV2) to 12 months post-procedure
Incidence of Renal Artery Re-intervention
Interventional procedure performed on the renal artery following completion of the renal denervation procedure and removal of the guide catheter.
Time frame: From baseline (SV2) to 12 months post-procedure
Incidence of Major Bleeding According to TIMI Definition
Intracranial hemorrhage; ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within seven days of the procedure)
Time frame: From baseline (SV2) to 12 months post-procedure
Incidence of Increase in Serum Creatinine >50%
Time frame: From baseline (SV2) to 12 months post-procedure