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This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Hypertension | Experimental | The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celsius® ThermoCool® Renal Denervation | Device | The investigational device is indicated for the treatment of resistant hypertension by renal denervation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure. | 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 |
|---|---|---|
| Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit | These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural 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:
Key Exclusion Criteria:
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The study enrollment took approximately 3 months, began on October 21, 2013 and completed on December 17, 2013. A total of 37 subjects were consented and 19 underwent treatment with the study catheter in 4 investigation sites in New Zealand, Czech Republic, and Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Artery Sympathetic Denervation | Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The Safety Analysis population which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Artery Sympathetic Denervation | Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure. | 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 |
|
12 Months
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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 Artery Sympathetic Denervation | Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial spasm | Vascular disorders | MedDRA | 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 |
| 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 |
| Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions. | 12 months post-procedure |
| Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure | The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure. | 12 months post-procedure |
| Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure | Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure. | 12 months post-procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit | These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural 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 consists of all enrolled subjects who have undergone insertion of the study ablation catheter. | Posted | Number | percentage of participants | 12 months post-procedure |
|
|
|
| Secondary | Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions. | Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery. | Posted | Mean | Standard Deviation | mmHg | 12 months post-procedure |
|
|
|
| Secondary | Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure | The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure. | Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery. | Posted | Number | percentage of participants | 12 months post-procedure |
|
|
|
| Secondary | Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure | Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure. | Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery. | Posted | Number | percentage of participants | 12 months post-procedure |
|
|
|
| 0 |
| 19 |
| 8 |
| 19 |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Renal Mass | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Mean Reduction in DBP |
|