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The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.
The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of renal artery sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD) Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Hypertension | Experimental | The catheter-based (device: Celsius® ThermoCool® RD) renal denervation will serve to treat resistant hypertension. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celsius® ThermoCool® RD | Device | The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation. |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure. | The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation. | 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure | These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events. |
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Inclusion Criteria:
Exclusion Criteria:
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After signing the inform of consent, subjects were evaluated on inclusion/exclusion criteria, anatomic eligibility, compliant with completing the subject diary. Thirty-three subjects failed and never underwent insertion of the study ablation catheter.
The study enrollment took approximately 11 months, began in December 2, 2012 and completed on November 4, 2013. A total of 68 subjects were consented and 35 started the renal denervation with the investigational ablation catheter.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Sympathetic Denervation | Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All treated subjects who underwent the renal sympathetic denervation procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Sympathetic Denervation | Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure. | The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation. | The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter. | Posted | Number | percentage of participants | 30 days post-procedure |
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Twelve months post procedure
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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 | Renal Sympathetic Denervation | Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin urine high | Investigations | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liesbeth Vanderlinden, Manager Clinical Research | Biosense Webster, EMEA | +32(0)2 7463527 | lvanderl@its.JNJ.com |
| ID | Term |
|---|---|
| D006977 | Hypertension, Renal |
| D000075222 | Essential Hypertension |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 12 months post-procedure |
| Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline. | From baseline to 1 ,3, 6 and 12 months post procedure |
| Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline. | From baseline to 3, 6 and 12 months post procedure |
| Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics). | At 1, 3, 6, and 12 month post-procedure |
| Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure | At 1, 3, 6, and 12 month post-procedure |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
|
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| Secondary | Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure | These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events. | The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter. | Posted | Number | percentage of participants | 12 months post-procedure |
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| Secondary | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline. | The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. . | Posted | Mean | Standard Deviation | mmHg | From baseline to 1 ,3, 6 and 12 months post procedure |
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| Secondary | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline. | The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. . | Posted | Mean | Standard Deviation | mmHg | From baseline to 3, 6 and 12 months post procedure |
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| Secondary | Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics). | The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. . | Posted | Number | percentage of participants | At 1, 3, 6, and 12 month post-procedure |
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| Secondary | Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure | The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. . | Posted | Number | percentage of participants | At 1, 3, 6, and 12 month post-procedure |
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| 7 |
| 35 |
| 23 |
| 35 |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Lumbar pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
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| Sudden death | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
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| Breathlessness | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Flu-like illness | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Function kidney decreased | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypertension worsened | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Incision site bleeding | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
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| Incision site hematoma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
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| Inflammation | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Lumbar pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
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| Middle ear infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
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| Numbness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Oedema | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Painful knee | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
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| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
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| Raised blood pressure | Investigations | MedDRA (16.1) | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
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| Renal function test | Investigations | MedDRA (16.1) | Systematic Assessment |
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| Serum potassium decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
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| Serum sodium decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
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| Spasm of artery | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
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| Swelling arm | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Urethral irritation | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
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| Vertebral artery stenosis | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| Systolic Mean Change from Baseline |
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| Diastolic Office Blood Pressure |
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| Diastolic Mean Change from Baseline |
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| Systolic Mean Change from Baseline |
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| Diastolic Office Blood Pressure |
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| Diastolic Mean Change from Baseline |
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