Hypertension, Hypertension,Essential
Conditions
Keywords
Renal Denervation, Neurolysis
Brief summary
To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.
Interventions
DRUGAlcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
OTHERSham control
endovascular, renal angiography
Sponsors
Ablative Solutions, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
Intervention model description
Subjects who continue to be eligible at the end of the run-in period will be randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site): * Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter * Sham Control Arm: only renal angiography performed
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg. 2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period. 3. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion criteria
1. Subject has renal artery anatomy abnormalities. 2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy. 3. Subject has documented sleep apnea. 4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure). 5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed. 7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Systolic Ambulatory Blood Pressure | Baseline to 8 weeks post-treatment | Change from baseline in mean 24-hour ambulatory systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Office DBP to 8 Weeks | 8 weeks | Change from Baseline in mean office DBP to 8 Weeks |
| Change in Mean Office DBP to 6 Months | 6 months | Change from Baseline in mean office DBP to 6 Months |
| Change in Mean Office DBP at 12 Months | 12 months | Change from Baseline in mean office DBP to 12 Months |
| Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | 6 months | Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months |
| Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months | 12 months | Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure |
| Change in Office SBP at 8 Weeks | 8 weeks | Change from Baseline in mean office SBP to Week 8 |
| Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | 8 weeks | Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure |
| Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | 6 months | Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure |
| Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | 12 months | Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure |
| Number of Participants With Major Adverse Events (MAEs) | 30 days post procedure | Number of participants with major adverse events (MAEs) 30 days post-procedure |
| Use of Antihypertensive Medication(s) | 8 weeks | Use of antihypertensive medication at 8 weeks |
| Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | 8 weeks | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks |
| Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | 6 months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months |
| Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | 12 months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months |
| Mean Daytime Ambulatory Diastolic Blood Pressure | 8 weeks | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks |
| Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | 6 months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months |
| Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | 12 months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months |
| Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | 8 weeks | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks |
| Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | 6 months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months |
| Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | 12 months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months |
| Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | 8 weeks | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks |
| Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | 6 months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months |
| Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | 12 months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months |
| Change in Mean Office SBP at 6 Months | 6 months | Change from Baseline in mean office SBP to 6 Months |
| Change in Mean Office SBP to 12 Months | 12 months | Change from Baseline in mean office SBP to 12 Months |
Countries
Belgium, France, Germany, United Kingdom
Participant flow
Pre-assignment details
Enrolled and consented (n=350)
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm: Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries | 50 |
| Sham Control Arm Only renal angiography performed
Sham control: endovascular, renal angiography | 56 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not completing the primary ABPM | 3 | 1 |
| Overall Study | Not meeting inclusion/exclusion criteria | 1 | 0 |
| Overall Study | Not receiving bilateral treatment or an unsuccessful procedure | 0 | 2 |
| Overall Study | Receiving antihypertensive medications prior to evaluation of the primary ABPM | 8 | 4 |
Baseline characteristics
| Characteristic | Total | Treatment Arm: | Sham Control Arm |
|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 11.3 | 53.8 years STANDARD_DEVIATION 11 | 54.4 years STANDARD_DEVIATION 11.5 |
| Angiographically determined coronary artery disease | 3 Participants | 2 Participants | 1 Participants |
| Diabetes (type 2) | 7 Participants | 2 Participants | 5 Participants |
| eGFR | 85.8 mL/min per 1.73 m^2 STANDARD_DEVIATION 13.4 | 85.8 mL/min per 1.73 m^2 STANDARD_DEVIATION 14 | 85.9 mL/min per 1.73 m^2 STANDARD_DEVIATION 13 |
| Peripheral vascular occlusive disease | 2 Participants | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Belgium | 2 participants | 1 participants | 1 participants |
| Region of Enrollment France | 13 participants | 7 participants | 6 participants |
| Region of Enrollment Germany | 58 participants | 28 participants | 30 participants |
| Region of Enrollment Ireland | 4 participants | 2 participants | 2 participants |
| Region of Enrollment Netherlands | 8 participants | 4 participants | 4 participants |
| Region of Enrollment United Kingdom | 16 participants | 7 participants | 9 participants |
| Region of Enrollment United States | 5 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 28 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 78 Participants | 40 Participants | 38 Participants |
| Smoking (current) | 11 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 50 |
| other Total, other adverse events | 42 / 56 | 41 / 50 |
| serious Total, serious adverse events | 9 / 56 | 7 / 50 |
Outcome results
Primary
Changes in Systolic Ambulatory Blood Pressure
Change from baseline in mean 24-hour ambulatory systolic blood pressure
Time frame: Baseline to 8 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Control Arm | Changes in Systolic Ambulatory Blood Pressure | -1.4 mmHg | Standard Deviation 8.6 |
| Treatment Arm: | Changes in Systolic Ambulatory Blood Pressure | -2.9 mmHg | Standard Deviation 7.4 |
Comparison: The null hypothesis to be tested is that there is no difference in the change in 24 hour mean SBP between treatment and sham control. The Type I error rate for rejecting the null hypothesis will be set at an alpha level of 0.05.p-value: 0.268295% CI: [-4.8, 1.7]ANCOVA
Secondary
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months
Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | Mean 24-hour ambulatory diastolic blood pressure | 81.0 mmHg | Standard Deviation 7.9 |
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | Change from baseline in Mean 24-hour ambulatory diastolic blood pressure | -9.8 mmHg | Standard Deviation 8.3 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | Mean 24-hour ambulatory diastolic blood pressure | 85.6 mmHg | Standard Deviation 8.7 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | Change from baseline in Mean 24-hour ambulatory diastolic blood pressure | -7.3 mmHg | Standard Deviation 7.5 |
p-value: 0.0341ANCOVA
Secondary
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months
Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | Mean 24-hour ambulatory diastolic blood pressure | 83.4 mmHg | Standard Deviation 9 |
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | Change from baseline in Mean 24-hour ambulatory diastolic blood pressure | -8.0 mmHg | Standard Deviation 8.5 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | Mean 24-hour ambulatory diastolic blood pressure | 83.0 mmHg | Standard Deviation 8.4 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | Change from baseline in Mean 24-hour ambulatory diastolic blood pressure | -9.3 mmHg | Standard Deviation 6.9 |
Secondary
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks
Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | Mean 24-hour ambulatory diastolic blood pressure | 91.0 mmHg | Standard Deviation 6.8 |
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from baseline in Mean 24-hour ambulatory diastolic blood pressure | -1.1 mmHg | Standard Deviation 6.6 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | Mean 24-hour ambulatory diastolic blood pressure | 92.2 mmHg | Standard Deviation 7.6 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from baseline in Mean 24-hour ambulatory diastolic blood pressure | -2.0 mmHg | Standard Deviation 5.1 |
Comparison: Between group differencep-value: 0.4734ANCOVA
Secondary
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months
Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months | Mean 24-hour SBP | 133.7 mmHg | Standard Deviation 11.3 |
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months | Change from baseline in mean 24-hour SBP | -15.9 mmHg | Standard Deviation 13.1 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months | Mean 24-hour SBP | 137.6 mmHg | Standard Deviation 11.4 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months | Change from baseline in mean 24-hour SBP | -10.6 mmHg | Standard Deviation 11.5 |
Comparison: Between group differencep-value: 0.0775ANCOVA
Secondary
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months
Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | Mean 24-Hour Ambulatory Systolic Blood Pressure | 135.1 mmHg | Standard Deviation 11.7 |
| Sham Control Arm | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | Change from baseline in Mean 24-Hour Ambulatory Systolic Blood Pressure | -13.4 mmHg | Standard Deviation 12.9 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | Mean 24-Hour Ambulatory Systolic Blood Pressure | 134.1 mmHg | Standard Deviation 11.6 |
| Treatment Arm: | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | Change from baseline in Mean 24-Hour Ambulatory Systolic Blood Pressure | -13.9 mmHg | Standard Deviation 11.6 |
Comparison: Difference between treatment armsp-value: 0.6964ANCOVA
Secondary
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months
Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | Mean Daytime Ambulatory Diastolic Blood Pressure | 86.0 mmHg | Standard Deviation 8.7 |
| Sham Control Arm | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure | -9.5 mmHg | Standard Deviation 8.7 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | Mean Daytime Ambulatory Diastolic Blood Pressure | 90.4 mmHg | Standard Deviation 9.6 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure | -7.6 mmHg | Standard Deviation 8.9 |
Secondary
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months
Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | Mean Daytime Ambulatory Diastolic Blood Pressure | 87.6 mmHg | Standard Deviation 9 |
| Sham Control Arm | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure | -8.9 mmHg | Standard Deviation 8.6 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | Mean Daytime Ambulatory Diastolic Blood Pressure | 87.8 mmHg | Standard Deviation 9.2 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure | -9.3 mmHg | Standard Deviation 8.9 |
Secondary
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | Mean Daytime Ambulatory Systolic Blood Pressure | 140.1 mmHg | Standard Deviation 12.1 |
| Sham Control Arm | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure | -15.5 mmHg | Standard Deviation 13.6 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | Mean Daytime Ambulatory Systolic Blood Pressure | 143.5 mmHg | Standard Deviation 12.6 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure | -10.5 mmHg | Standard Deviation 12.8 |
Secondary
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | Mean Daytime Ambulatory Systolic Blood Pressur | 140.6 mmHg | Standard Deviation 12.3 |
| Sham Control Arm | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months | -14.5 mmHg | Standard Deviation 13.7 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | Mean Daytime Ambulatory Systolic Blood Pressur | 139.7 mmHg | Standard Deviation 12.8 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months | -14.0 mmHg | Standard Deviation 13.3 |
Secondary
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | Mean Daytime Ambulatory Systolic Blood Pressure | 153.2 mmHg | Standard Deviation 12 |
| Sham Control Arm | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure | -1.7 mmHg | Standard Deviation 9.9 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | Mean Daytime Ambulatory Systolic Blood Pressure | 150.6 mmHg | Standard Deviation 10.5 |
| Treatment Arm: | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure | -3.2 mmHg | Standard Deviation 9.5 |
Secondary
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months
Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | Mean Nighttime Ambulatory Diastolic Blood Pressure | 72.8 mmHg | Standard Deviation 8.2 |
| Sham Control Arm | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure | -10.8 mmHg | Standard Deviation 9.7 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | Mean Nighttime Ambulatory Diastolic Blood Pressure | 77.4 mmHg | Standard Deviation 7.8 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure | -7.6 mmHg | Standard Deviation 8.1 |
Secondary
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months
Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | Mean Nighttime Ambulatory Diastolic Blood Pressure | 75.8 mmHg | Standard Deviation 10.8 |
| Sham Control Arm | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure | -7.4 mmHg | Standard Deviation 10.4 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | Mean Nighttime Ambulatory Diastolic Blood Pressure | 75.5 mmHg | Standard Deviation 9.2 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure | -9.0 mmHg | Standard Deviation 8 |
Secondary
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks
Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | Mean Nighttime Ambulatory Diastolic Blood Pressure | 82.5 mmHg | Standard Deviation 12.4 |
| Sham Control Arm | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure | -0.44 mmHg | Standard Deviation 10.17 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | Mean Nighttime Ambulatory Diastolic Blood Pressure | 81.5 mmHg | Standard Deviation 8.4 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure | -2.5 mmHg | Standard Deviation 7.3 |
Secondary
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months
Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | Mean Nighttime Ambulatory Systolic Blood Pressure | 125.6 mmHg | Standard Deviation 13.9 |
| Sham Control Arm | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure | -12.8 mmHg | Standard Deviation 14.1 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | Mean Nighttime Ambulatory Systolic Blood Pressure | 125.4 mmHg | Standard Deviation 12.1 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure | -13.4 mmHg | Standard Deviation 12.7 |
Secondary
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks
Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | Mean Nighttime Ambulatory Systolic Blood Pressure | 136.9 mmHg | Standard Deviation 14.6 |
| Sham Control Arm | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure | -0.58 mmHg | Standard Deviation 12.17 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | Mean Nighttime Ambulatory Systolic Blood Pressure | 134.4 mmHg | Standard Deviation 11.6 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure | -3.3 mmHg | Standard Deviation 9.4 |
Secondary
Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Mean Nighttime Ambulatory Systolic Blood Pressure | 123.1 mmHg | Standard Deviation 12.3 |
| Sham Control Arm | Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure | -17.1 mmHg | Standard Deviation 14.4 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Mean Nighttime Ambulatory Systolic Blood Pressure | 127.8 mmHg | Standard Deviation 10.7 |
| Treatment Arm: | Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure | -11.8 mmHg | Standard Deviation 12.2 |
Secondary
Change in Mean Office DBP at 12 Months
Change from Baseline in mean office DBP to 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Office DBP at 12 Months | Change from Baseline in mean office DBP to 12 Months | -9.6 mmHg | Standard Deviation 11 |
| Sham Control Arm | Change in Mean Office DBP at 12 Months | mean office DBP | 88.5 mmHg | Standard Deviation 11.5 |
| Treatment Arm: | Change in Mean Office DBP at 12 Months | mean office DBP | 91.0 mmHg | Standard Deviation 11 |
| Treatment Arm: | Change in Mean Office DBP at 12 Months | Change from Baseline in mean office DBP to 12 Months | -9.4 mmHg | Standard Deviation 9.4 |
Secondary
Change in Mean Office DBP to 6 Months
Change from Baseline in mean office DBP to 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Office DBP to 6 Months | mean office DBP | 89.7 mmHg | Standard Deviation 10.5 |
| Sham Control Arm | Change in Mean Office DBP to 6 Months | Change from Baseline in mean office DBP to 6 Months | -8.4 mmHg | Standard Deviation 9.5 |
| Treatment Arm: | Change in Mean Office DBP to 6 Months | mean office DBP | 90.4 mmHg | Standard Deviation 9.4 |
| Treatment Arm: | Change in Mean Office DBP to 6 Months | Change from Baseline in mean office DBP to 6 Months | -10.0 mmHg | Standard Deviation 9 |
Secondary
Change in Mean Office DBP to 8 Weeks
Change from Baseline in mean office DBP to 8 Weeks
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Office DBP to 8 Weeks | mean office DBP | 97.3 mmHg | Standard Deviation 10.9 |
| Sham Control Arm | Change in Mean Office DBP to 8 Weeks | Change from Baseline in mean office DBP to 8 Weeks | -1.1 mmHg | Standard Deviation 8.8 |
| Treatment Arm: | Change in Mean Office DBP to 8 Weeks | mean office DBP | 97.0 mmHg | Standard Deviation 9.4 |
| Treatment Arm: | Change in Mean Office DBP to 8 Weeks | Change from Baseline in mean office DBP to 8 Weeks | -3.5 mmHg | Standard Deviation 7.6 |
Secondary
Change in Mean Office SBP at 6 Months
Change from Baseline in mean office SBP to 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Office SBP at 6 Months | mean office SBP | 145.7 mmHg | Standard Deviation 14.3 |
| Sham Control Arm | Change in Mean Office SBP at 6 Months | Change from Baseline in mean office SBP to 6 Months | -14.7 mmHg | Standard Deviation 15.7 |
| Treatment Arm: | Change in Mean Office SBP at 6 Months | mean office SBP | 146.1 mmHg | Standard Deviation 16.4 |
| Treatment Arm: | Change in Mean Office SBP at 6 Months | Change from Baseline in mean office SBP to 6 Months | -12.9 mmHg | Standard Deviation 15.6 |
Secondary
Change in Mean Office SBP to 12 Months
Change from Baseline in mean office SBP to 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Mean Office SBP to 12 Months | mean office SBP | 147.8 mmHg | Standard Deviation 15.1 |
| Sham Control Arm | Change in Mean Office SBP to 12 Months | Change from Baseline in mean office SBP to 12 Months | -13.2 mmHg | Standard Deviation 16.6 |
| Treatment Arm: | Change in Mean Office SBP to 12 Months | mean office SBP | 147.9 mmHg | Standard Deviation 18.5 |
| Treatment Arm: | Change in Mean Office SBP to 12 Months | Change from Baseline in mean office SBP to 12 Months | -11.0 mmHg | Standard Deviation 15.3 |
Secondary
Change in Office SBP at 8 Weeks
Change from Baseline in mean office SBP to Week 8
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Change in Office SBP at 8 Weeks | Office SBP | 160.6 mmHg | Standard Deviation 16.3 |
| Sham Control Arm | Change in Office SBP at 8 Weeks | Change from Baseline in mean office SBP | 0.63 mmHg | Standard Deviation 13.24 |
| Treatment Arm: | Change in Office SBP at 8 Weeks | Office SBP | 155.4 mmHg | Standard Deviation 14.3 |
| Treatment Arm: | Change in Office SBP at 8 Weeks | Change from Baseline in mean office SBP | -4.0 mmHg | Standard Deviation 12.6 |
Secondary
Mean Daytime Ambulatory Diastolic Blood Pressure
Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Control Arm | Mean Daytime Ambulatory Diastolic Blood Pressure | Mean Daytime Ambulatory Diastolic Blood Pressure | 94.7 mmHg | Standard Deviation 9.7 |
| Sham Control Arm | Mean Daytime Ambulatory Diastolic Blood Pressure | hange from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure | -1.4 mmHg | Standard Deviation 6.8 |
| Treatment Arm: | Mean Daytime Ambulatory Diastolic Blood Pressure | Mean Daytime Ambulatory Diastolic Blood Pressure | 95.2 mmHg | Standard Deviation 7.5 |
| Treatment Arm: | Mean Daytime Ambulatory Diastolic Blood Pressure | hange from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure | -2.3 mmHg | Standard Deviation 6.8 |
Secondary
Number of Participants With Major Adverse Events (MAEs)
Number of participants with major adverse events (MAEs) 30 days post-procedure
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sham Control Arm | Number of Participants With Major Adverse Events (MAEs) | 1 Participants |
| Treatment Arm: | Number of Participants With Major Adverse Events (MAEs) | 1 Participants |
Secondary
Use of Antihypertensive Medication(s)
Use of antihypertensive medication at 8 weeks
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Control Arm | Use of Antihypertensive Medication(s) | 0.089 medications | Standard Deviation 0.288 |
| Treatment Arm: | Use of Antihypertensive Medication(s) | 0.060 medications | Standard Deviation 0.24 |
p-value: 0.57395% CI: [-0.132, 0.073]Fisher Exact