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The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).
Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). |
|
| Masked Procedure | Sham Comparator | Percutaneous renal angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation (Vessix) | Device | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator |
|
| Measure | Description | Time Frame |
|---|---|---|
| OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks | Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control) | Through 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations Due to Severe Hypotension/Syncope | Number of hospitalizations due to severe hypotension/syncope through 6 months. | Through 6 months |
| Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B Leon, MD | Columbia University | Principal Investigator |
| Michael Weber, MD | SUNY Downstate College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, PC | Birmingham | Alabama | 35211 | United States | ||
| Cedars - Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32081240 | Derived | Weber MA, Kirtane AJ, Weir MR, Radhakrishnan J, Das T, Berk M, Mendelsohn F, Bouchard A, Larrain G, Haase M, Diaz-Cartelle J, Leon MB. The REDUCE HTN: REINFORCE: Randomized, Sham-Controlled Trial of Bipolar Radiofrequency Renal Denervation for the Treatment of Hypertension. JACC Cardiovasc Interv. 2020 Feb 24;13(4):461-470. doi: 10.1016/j.jcin.2019.10.061. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Denervation | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator |
| FG001 | Masked Procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2019 |
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| Renal Angiography | Device | Percutaneous renal angiography |
|
|
Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.
| 4 weeks |
| Renal Artery Dissection or Perforation Requiring Intervention | Number of renal artery dissection or perforation requiring intervention through 4 weeks. | 4 weeks |
| Vascular Complications | Number of vascular complications through 4 weeks. | 4 weeks |
| Significant New Renal Artery Stenosis | Number of significant new renal artery stenosis events through 6 months. | 6 months |
| Number of Subjects Utilizing Anti-hypertensive Medications | Number of subjects utilizing anti-hypertensive medications at 3 months. | 3 months |
| Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months | Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline | 6 Months |
| Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months | Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline. | 6 Months |
| Number of Subjects Utilizing Anti-hypertensive Medications | Number of subjects utilizing anti-hypertensive medications at 6 months | 6 months |
| Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure | Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months | 12 Months |
| Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure | Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months | 12 Months |
| All-Cause Death | Number of all causes of death through 24 months | 24 Months |
| Number of Participants With Renal Failure | Number of renal failure events through 24 months | 24 Months |
| Number of Participants With Hypertensive Crisis | Number of hypertensive crisis events through 24 months | 24 Months |
| Mean Reduction in Average Office-based Systolic Blood Pressure | Mean Reduction in Average office-based systolic blood pressure through 24 months | 24 Months |
| Mean Reduction in Average Office-based Diastolic Blood Pressure | Mean Reduction in Office-based diastolic blood pressure through 24 months | 24 Months |
| Percent of Subjects at Target Blood Pressure | Percent of subjects at target blood pressure through 24 months | 24 Months |
| Congestive Heart Failure | Number of subjects with congestive heart failure through 24 months | 24 Months |
| Myocardial Infarction | Number of subjects who experience myocardial infarction through 24 months | 24 Months |
| Stroke | Number of subjects experiencing stroke through 24 months | 24 Months |
| Los Angeles |
| California |
| 90048 |
| United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| Dallas Medical Center | Dallas | Texas | 75006 | United States |
| Cardiovascular Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| Aspirus Heart and Vascular Institute | Wausau | Wisconsin | 54401 | United States |
Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| COMPLETED |
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| NOT COMPLETED |
|
The baseline analysis population is not different from the assignment in the participant flow. Of note, subjects with multiple ethnic categories are considered independently.
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Denervation | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator |
| BG001 | Masked Procedure | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Left Renal Artery | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Count of Participants | Participants |
| |||||||||||||||
| Left Renal Accessory Artery | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Count of Participants | Participants |
| |||||||||||||||
| Right Renal Artery | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Count of Participants | Participants |
| |||||||||||||||
| Right Renal Accessory Artery | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Count of Participants | Participants |
| |||||||||||||||
| Max Renal Artery Diameter | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Reference Renal Artery Diameter | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Mean | Standard Deviation | mm |
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| Renal Artery Length | Measurements are pre-procedure renal artery characteristics as reported by the core lab. | Mean | Standard Deviation | mm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks | Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control) | Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | Through 8 weeks |
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| ||||||||||||||||||||||||||||
| Secondary | Number of Hospitalizations Due to Severe Hypotension/Syncope | Number of hospitalizations due to severe hypotension/syncope through 6 months. | Posted | Count of Participants | Participants | Through 6 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it | Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks. | Posted | Count of Participants | Participants | 4 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Renal Artery Dissection or Perforation Requiring Intervention | Number of renal artery dissection or perforation requiring intervention through 4 weeks. | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Vascular Complications | Number of vascular complications through 4 weeks. | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Significant New Renal Artery Stenosis | Number of significant new renal artery stenosis events through 6 months. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Subjects Utilizing Anti-hypertensive Medications | Number of subjects utilizing anti-hypertensive medications at 3 months. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months | Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline | Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | 6 Months |
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| Secondary | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months | Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline. | Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | 6 Months |
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| Secondary | Number of Subjects Utilizing Anti-hypertensive Medications | Number of subjects utilizing anti-hypertensive medications at 6 months | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure | Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months | Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | 12 Months |
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| Secondary | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure | Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months | Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | 12 Months |
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| Secondary | All-Cause Death | Number of all causes of death through 24 months | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Number of Participants With Renal Failure | Number of renal failure events through 24 months | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Number of Participants With Hypertensive Crisis | Number of hypertensive crisis events through 24 months | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Mean Reduction in Average Office-based Systolic Blood Pressure | Mean Reduction in Average office-based systolic blood pressure through 24 months | Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | 24 Months |
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| |||||||||||||||||||||||||||||
| Secondary | Mean Reduction in Average Office-based Diastolic Blood Pressure | Mean Reduction in Office-based diastolic blood pressure through 24 months | Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment. | Posted | Mean | Standard Deviation | mmHg | 24 Months |
|
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| Secondary | Percent of Subjects at Target Blood Pressure | Percent of subjects at target blood pressure through 24 months | Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment. | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Congestive Heart Failure | Number of subjects with congestive heart failure through 24 months | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Myocardial Infarction | Number of subjects who experience myocardial infarction through 24 months | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Stroke | Number of subjects experiencing stroke through 24 months | Posted | Count of Participants | Participants | 24 Months |
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Adverse events will be collected through 36 months from enrollment.
Enrollment terminated. No endpoint analysis conducted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System) Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator Through 6 Months | 0 | 34 | 5 | 34 | 27 | 34 |
| EG001 | Masked Procedure - Control Group | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography | 0 | 17 | 5 | 17 | 13 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accelerated hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Femoral artery occlusion | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Osteomyelitis chronic | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Arterial spasm | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Mental impairment | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Pulpitis dental | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Renal artery dissection | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Blood aldosterone increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
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| Carotid bruit | Investigations | MedDRA (10.0) | Non-systematic Assessment |
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| Heart sounds abnormal | Investigations | MedDRA (10.0) | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Boston Scientific | 970-294-4082 | nicole.kilburn@bsci.com |
| Mar 29, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
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| Caucasian |
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| Hispanic or Latino |
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| Black, of African Heritage |
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