Hypertension
Conditions
Keywords
hypertension, resistant hypertension, renal denervation
Brief summary
The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with drug-resistant uncontrolled hypertension.
Detailed description
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. Subject randomized to the treatment group will be followed up for three years post procedure.
Interventions
DEVICEEnligHTN Renal Denervation
Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
PROCEDURESham
Renal artery angiogram
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is ≥18 years of age and ≤ 80 years of age at time of informed consent for participation in the clinical investigation * Subject must be able and willing to provide written informed consent * Subject must be able and willing to comply with the required follow-up schedule * Subject has an office Systolic Blood Pressure ≥ 160 mmHg based on an average of 3 Blood Pressure readings at the confirmatory visit (except for subjects with Diabetes Mellitus Type II who must demonstrate an office Systolic Blood Pressure of ≥ 150 mmHg) * Subject has a daytime mean Systolic 24-hour Ambulatory Blood Pressure value of ≥ 140 mmHg as measured during the two week screening period and confirmed at the confirmatory visit * Subject is taking ≥ 3 antihypertensive medications concurrently at full tolerated doses (this must include one diuretic) or subject is taking a diuretic and has a documented intolerance to at least two (2) out of the three (3) remaining major classes of anti-hypertensives (ACE / ARB, Calcium Channel Blockers, Beta blockers and is unable to take 3 anti-hypertensive drugs) o Intolerance is defined as an absolute contraindication to an anti-hypertensive medication according to the approved labeling or an inability to take an anti-hypertensive medication as prescribed due to an adverse drug effect including an immune mediated response or interaction with other medications. * Subjects must be on a stable antihypertensive medication regimen for a minimum of 2 weeks prior to completing the initial screening visit and the medication regimen must remain unchanged during the 2 week screening period following signing consent. Subject must be assessed at the confirmatory visit with no expected changes for at least six (6) months
Exclusion criteria
* Subject has had a previous renal denervation attempt * Subject has known cause of secondary hypertension other than sleep apnea * Subjects with significant renovascular abnormalities such as renal artery stenosis \>30%, previous renal stenting or angioplasty, renal artery occlusion, renal vein thrombosis, renal aneurysm or renal atheroembolism * Subject has had a myocardial infarction, unstable angina pectoris, or cerebrovascular accident \< 180 days prior to enrollment * Subject has hemodynamically significant valvular heart disease as determined by a Study Investigator * Subject is expected to have any cardiovascular intervention within 180 days of enrollment * Subject has blood clotting abnormalities such as thrombocytopenia, hemophilia, or significant anemia * Subject life expectancy is \< 12 months, as determined by a Study Investigator * Subject is participating in another Clinical Investigation (IND or IDE) * Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods * Subject has active systemic infection as determined by a Study Investigator * Subject has main renal arteries with diameter(s) \< 4 mm in diameter or \< 20 mm in length or multiple renal arteries where the main renal arteries supply \<75% of the kidney * Subject has eGFR \< 45 mL/min per 1.73 m2 using the MDRD formula * Subject has evidence of significant AAA defined as an aneurysm size of ≥5.0 cm in width and/or involving the renal arteries, and/or requiring surgical or percutaneous intervention within 6 months of enrollment. * Subject has had \>1 in-patient hospitalization for a hypertensive crisis within 12 months * Subject has a condition which would interfere with the accurate interpretation of the study endpoints * Any condition that would prohibit or interfere with the ability to obtain accurate Blood Pressure measurements using the CIP specific automatic Blood Pressure monitor * Subject has Systolic Blood Pressure values which are greater than 20mmHg apart after six (6) measurements as assessed at the confirmatory visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC). | 6 months post randomization | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred. |
| The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups | 6 months post randomization | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months | 6 months post randomization | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. |
| The Number of Subjects That Experience Each Type of MAE | 6 months post randomization | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. |
| Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | 6 months post randomization, and all follow-up timepoints | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. |
| Reduction in Ambulatory Blood Pressure (ABP) Parameters | baseline, 6 months post randomization, and all follow-up timepoints | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renal Denervation Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system | 2 |
| Sham Procedure Sham procedure
Sham: Renal artery angiogram | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Renal Denervation | Total | Sham Procedure |
|---|---|---|---|
| 24-Hr Ambulatory Diastolic BP | 92.5 mmHg STANDARD_DEVIATION 24.7 | 83.9 mmHg STANDARD_DEVIATION 17.4 | 75.4 mmHg STANDARD_DEVIATION 1.4 |
| 24-Hr Ambulatory Heart Rate | 68.2 beats/minute STANDARD_DEVIATION 2.9 | 64.3 beats/minute STANDARD_DEVIATION 10.4 | 60.5 beats/minute STANDARD_DEVIATION 16 |
| 24-Hr Ambulatory Systolic BP | 151.7 mmHg STANDARD_DEVIATION 22.9 | 153.5 mmHg STANDARD_DEVIATION 13.6 | 155.3 mmHg STANDARD_DEVIATION 4.3 |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 8.9 | 57.2 years STANDARD_DEVIATION 7.4 | 60.4 years STANDARD_DEVIATION 6.7 |
| BMI | 27.9 kg/m^2 STANDARD_DEVIATION 10.6 | 32.2 kg/m^2 STANDARD_DEVIATION 8.7 | 36.5 kg/m^2 STANDARD_DEVIATION 6.2 |
| Coronary Artery Disease No | 1 participants | 3 participants | 2 participants |
| Coronary Artery Disease Yes | 1 participants | 1 participants | 0 participants |
| Cystatin C | 0.76 mg/L STANDARD_DEVIATION 0.25 | 0.87 mg/L STANDARD_DEVIATION 0.22 | 0.98 mg/L STANDARD_DEVIATION 0.18 |
| Daytime Ambulatory Diastolic BP | 99.8 mmHg STANDARD_DEVIATION 27.6 | 87.7 mmHg STANDARD_DEVIATION 21.2 | 75.6 mmHg STANDARD_DEVIATION 1.8 |
| Daytime Ambulatory Heart Rate | 69.4 beats/minute STANDARD_DEVIATION 1.6 | 65.0 beats/minute STANDARD_DEVIATION 11.7 | 60.6 beats/minute STANDARD_DEVIATION 18.3 |
| Daytime Ambulatory Systolic BP | 161.4 mmHg STANDARD_DEVIATION 27 | 158.2 mmHg STANDARD_DEVIATION 16.1 | 155.0 mmHg STANDARD_DEVIATION 2.7 |
| eGFR | 91.0 mL/min/1.73 m2 STANDARD_DEVIATION 26.9 | 81.3 mL/min/1.73 m2 STANDARD_DEVIATION 21 | 71.5 mL/min/1.73 m2 STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 172.9 centimeters STANDARD_DEVIATION 14.1 | 172.2 centimeters STANDARD_DEVIATION 8.7 | 171.5 centimeters STANDARD_DEVIATION 5.4 |
| Hyperlipidemia No | 1 participants | 1 participants | 0 participants |
| Hyperlipidemia Yes | 1 participants | 3 participants | 2 participants |
| Number of Anti-hypertensive medications | 4.0 number of anti-hypertensive medications STANDARD_DEVIATION 1.4 | 4.8 number of anti-hypertensive medications STANDARD_DEVIATION 1.3 | 5.5 number of anti-hypertensive medications STANDARD_DEVIATION 0.7 |
| Obstructive Sleep Apnea No | 2 participants | 3 participants | 1 participants |
| Obstructive Sleep Apnea Yes | 0 participants | 1 participants | 1 participants |
| Office Diastolic BP | 111.5 mmHg STANDARD_DEVIATION 4.9 | 99.8 mmHg STANDARD_DEVIATION 13.9 | 88.0 mmHg STANDARD_DEVIATION 1.4 |
| Office Heart Rate | 76.5 beats/minute STANDARD_DEVIATION 12 | 67.5 beats/minute STANDARD_DEVIATION 13.3 | 58.5 beats/minute STANDARD_DEVIATION 7.8 |
| Office Systolic BP | 178.0 mmHg STANDARD_DEVIATION 17 | 188.8 mmHg STANDARD_DEVIATION 25.5 | 199.5 mmHg STANDARD_DEVIATION 34.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Renal Artery Stenosis No | 2 participants | 4 participants | 2 participants |
| Renal Artery Stenosis Yes | 0 participants | 0 participants | 0 participants |
| Serum Creatinine | 69.0 umol/L STANDARD_DEVIATION 26.9 | 76.0 umol/L STANDARD_DEVIATION 17.5 | 83.0 umol/L STANDARD_DEVIATION 1.4 |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Type II Diabetes No | 2 participants | 4 participants | 2 participants |
| Type II Diabetes Yes | 0 participants | 0 participants | 0 participants |
| Urine Albumin to Creatinine Ratio | 10.5 mg/g STANDARD_DEVIATION 2.1 | 54.3 mg/g STANDARD_DEVIATION 79.4 | 98.0 mg/g STANDARD_DEVIATION 106.1 |
| Weight | 81.0 kilograms STANDARD_DEVIATION 18.4 | 94.5 kilograms STANDARD_DEVIATION 23.7 | 108.0 kilograms STANDARD_DEVIATION 25 |
| Years with hypertension | 30.5 years STANDARD_DEVIATION 0.7 | 32.3 years STANDARD_DEVIATION 3.2 | 36.0 years STANDARD_DEVIATION 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 2 / 2 | 0 / 2 |
| serious Total, serious adverse events | 2 / 2 | 0 / 2 |
Outcome results
Primary
The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups
Time frame: 6 months post randomization
Population: The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct a comparison between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups | -22.5 mmHg | Standard Deviation 36 |
Primary
The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.
Time frame: 6 months post randomization
Population: All subjects randomized to the EnligHTN procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Renal Denervation | The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC). | Proportion of Subjects with MAE | 0 percentage of participants |
| Renal Denervation | The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC). | Proportion Subjects without MAE | 100 percentage of participants |
Secondary
Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Time frame: 6 months post randomization
Population: Subjects who received renal denervation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months | 0 Participants |
Secondary
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Time frame: 6 months post randomization, and all follow-up timepoints
Population: Subjects who received renal denervation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥10mmHg SBP reduction from BL(6M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥10mmHg SBP reduction from BL(12M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥10mmHg SBP reduction from BL(18M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥10mmHg SBP reduction from BL(24M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥10mmHg SBP reduction from BL(30M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥10mmHg SBP reduction from BL(36M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥15mmHg SBP reduction from BL (6M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥15mmHg SBP reduction from BL (12M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥15mmHg SBP reduction from BL (18M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥15mmHg SBP reduction from BL (24M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥15mmHg SBP reduction from BL (30M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥15mmHg SBP reduction from BL (36M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥20mmHg SBP reduction from BL (6M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥20mmHg SBP reduction from BL (12M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥20mmHg SBP reduction from BL (18M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥20mmHg SBP reduction from BL (24M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥20mmHg SBP reduction from BL (30M) | 1 Participants |
| Renal Denervation | Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | Responders ≥20mmHg SBP reduction from BL (36M) | 1 Participants |
Secondary
Reduction in Ambulatory Blood Pressure (ABP) Parameters
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Time frame: baseline, 6 months post randomization, and all follow-up timepoints
Population: All subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 36 Month 24Hr Diastolic | 62.4 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 18 Month 24Hr Diastolic | 71.7 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 24 Month 24Hr Diastolic | 65.2 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 30 Month 24Hr Diastolic | 61.3 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | Baseline 24Hr Systolic | 151.7 mmHg | Standard Deviation 22.9 |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 1 Month 24Hr Systolic | 128.8 mmHg | Standard Deviation 1.3 |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 3 Month 24Hr Systolic | 158.9 mmHg | Standard Deviation 50.8 |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 6 Month 24Hr Systolic | 124.7 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 12 Month 24Hr Systolic | 121.3 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 18 Month 24Hr Systolic | 133.6 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 24 Month 24Hr Systolic | 123.1 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 30 Month 24Hr Systolic | 123.2 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 36 Month 24Hr Systolic | 121.5 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | Baseline 24Hr Diastolic | 92.5 mmHg | Standard Deviation 24.7 |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 1 Month 24Hr Diastolic | 78.8 mmHg | Standard Deviation 13.5 |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 3 Month 24Hr Diastolic | 93.9 mmHg | Standard Deviation 37.8 |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 6 Month 24Hr Diastolic | 66.2 mmHg | — |
| Renal Denervation | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 12 Month 24Hr Diastolic | 67.3 mmHg | — |
| Sham Procedure | Reduction in Ambulatory Blood Pressure (ABP) Parameters | Baseline 24Hr Systolic | 155.3 mmHg | Standard Deviation 4.3 |
| Sham Procedure | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 1 Month 24Hr Diastolic | 73.9 mmHg | Standard Deviation 4.9 |
| Sham Procedure | Reduction in Ambulatory Blood Pressure (ABP) Parameters | 1 Month 24Hr Systolic | 155.5 mmHg | Standard Deviation 6.8 |
| Sham Procedure | Reduction in Ambulatory Blood Pressure (ABP) Parameters | Baseline 24Hr Diastolic | 75.4 mmHg | Standard Deviation 1.4 |
Secondary
The Number of Subjects That Experience Each Type of MAE
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Time frame: 6 months post randomization
Population: Subjects who received renal denervation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | All Cause Mortality | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | End Stage Renal Disease (eGFR <15ml/min/m2) | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | Significant Embolic Event | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | Renal Artery Perforation | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | Renal Artery Dissection | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | Vascular Access Site Complication | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | Hypertensive Crisis | 0 Participants |
| Renal Denervation | The Number of Subjects That Experience Each Type of MAE | Renal Artery Stenosis | 0 Participants |