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Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation | Experimental | Catheter-based Renal Sympathetic Denervation Ablation Arm |
|
| VT ablation alone | Placebo Comparator | No further therapy in addition to VT ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal sympathetic denervation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From First Event Requiring ICD Therapy | Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Appropriate ICD Shocks for Ventricular Arrhythmia | An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | at 24 months |
| Number of Inappropriate ICD Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Y Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| Homolka Hospital |
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21 participants received ID numbers because they were consented. 3 patients were screen failures due to accessibility of renal vasculature and Investigator discretion.
1 patient was a non-randomized roll- in where data was not collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | VT Ablation Alone | VT ablation alone: Placebo arm will receive standard VT ablation using current techniques |
| FG001 | Renal Sympathetic Denervation | Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VT Ablation Alone | VT ablation alone: Placebo arm will receive standard VT ablation using current techniques |
| BG001 | Renal Sympathetic Denervation | Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion). |
| 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 | Freedom From First Event Requiring ICD Therapy | Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months | Posted | Number | probability of freedom | 24 months |
|
24 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 Sympathetic Denervation | Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VT recurrence | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VT recurrence | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Betsy Ellsworth, Research Program Director | Icahn School of Medicine at Mo | 212 824 8902 | betsy.ellsworth@mountsinai.org |
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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 | Nov 1, 2012 | Feb 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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|
|
| VT ablation alone | Device | Placebo arm will receive standard VT ablation using current techniques |
|
Number of inappropriate ICD therapy including both appropriate and inappropriate shocks
| at 24 months |
| All ICD Therapies (Appropriate + Inappropriate) | cumulative ICD therapies including both appropriate and inappropriate shocks | 24 months |
| Number of Participants With Mortality, ICD Storm and Incessant VT | Number of Participants with a composite of Mortality, ICD storm, and Incessant VT | 24 months |
| Number of Participants With Hospitalizations for Cardiovascular Causes | 24 months |
| Number of Episodes of Total VT Burden | Total VT burden (Number of episodes) | at 24 months |
| Number of Participants With All-Cause Mortality | 24 months |
| Number of Participants With Occurrences of ICD Storm | The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours. | 24 months |
| Change in Brain Natriuretic Peptide (BNP) | Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline. | at baseline and at 12 months |
| Differences in BUN/Creatinine Measurements | Differences in BUN/creatinine measurements compared at 12 months to baseline. | baseline and 12 months |
| Change in LV Size | LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline | baseline and 12 months |
| Number of Procedure-related Adverse Events | Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction. | 24 months |
| Changes in Mean Arterial Pressure | Change in mean arterial pressure | baseline and 24 months |
| Number of Participants With Orthostatic Hypertension | Number of participants with other individual complication rates specifically orthostatic hypertension | 24 months |
| Number of Participants With Other Complications | Other individual complication rates including, but not limited to MI and death | at 24 months |
| Number of Occurrences of Major Complication Rate | 30-day Major Complication Rate defined as death, stroke, MI or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer) | 30 days |
| Procedure Time | Renal Denervation Procedure time | during procedure |
| Prague |
| 15030 |
| Czechia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | VT Ablation Alone | VT ablation alone: Placebo arm will receive standard VT ablation using current techniques |
|
|
| Secondary | Number of Appropriate ICD Shocks for Ventricular Arrhythmia | An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | Posted | Number | occurrences | at 24 months |
|
|
|
| Secondary | Number of Inappropriate ICD Therapy | Number of inappropriate ICD therapy including both appropriate and inappropriate shocks | Posted | Number | occurrences | at 24 months |
|
|
|
| Secondary | All ICD Therapies (Appropriate + Inappropriate) | cumulative ICD therapies including both appropriate and inappropriate shocks | Posted | Number | occurrences | 24 months |
|
|
|
| Secondary | Number of Participants With Mortality, ICD Storm and Incessant VT | Number of Participants with a composite of Mortality, ICD storm, and Incessant VT | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Participants With Hospitalizations for Cardiovascular Causes | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Episodes of Total VT Burden | Total VT burden (Number of episodes) | Posted | Number | episodes | at 24 months |
|
|
|
| Secondary | Number of Participants With All-Cause Mortality | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Participants With Occurrences of ICD Storm | The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Change in Brain Natriuretic Peptide (BNP) | Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline. | results only for those participants who have both timepoint data | Posted | Mean | Standard Deviation | mg/dL | at baseline and at 12 months |
|
|
|
| Secondary | Differences in BUN/Creatinine Measurements | Differences in BUN/creatinine measurements compared at 12 months to baseline. | Results only available for participants with data for both timepoints. | Posted | Mean | Standard Deviation | mg/dL | baseline and 12 months |
|
|
|
| Secondary | Change in LV Size | LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline | Results only available for participants with data for both timepoints. | Posted | Mean | Standard Deviation | cm | baseline and 12 months |
|
|
|
| Secondary | Number of Procedure-related Adverse Events | Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction. | Posted | Number | events | 24 months |
|
|
|
| Secondary | Changes in Mean Arterial Pressure | Change in mean arterial pressure | Results only available for participants with data for both timepoints. | Posted | Mean | Standard Deviation | mmHg | baseline and 24 months |
|
|
|
| Secondary | Number of Participants With Orthostatic Hypertension | Number of participants with other individual complication rates specifically orthostatic hypertension | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Participants With Other Complications | Other individual complication rates including, but not limited to MI and death | Posted | Count of Participants | Participants | at 24 months |
|
|
|
| Secondary | Number of Occurrences of Major Complication Rate | 30-day Major Complication Rate defined as death, stroke, MI or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer) | Posted | Number | occurrences | 30 days |
|
|
|
| Secondary | Procedure Time | Renal Denervation Procedure time | Results only for those participants who underwent renal sympathetic denervation | Posted | Mean | Standard Deviation | minutes | during procedure |
|
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| 5 |
| 9 |
| EG001 | VT Ablation Alone | No further therapy in addition to VT ablation VT ablation alone: Placebo arm will receive standard VT ablation using current techniques | 0 | 8 | 2 | 8 | 3 | 8 |
| Non-sustained VT | Cardiac disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Macrohematuria | Renal and urinary disorders | Systematic Assessment |
|
| AF with urosepsis | General disorders | Systematic Assessment |
|
| Worsening heart failure/Total artifical heart implant | Cardiac disorders | Systematic Assessment |
|
| Pseudoaneurysm at septal aspect of LV apex | Cardiac disorders | Systematic Assessment |
|
| Dissection of left external iliac artery | Cardiac disorders | Systematic Assessment |
|
| Paresthesia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| LUE Cephalic vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Hypotension with pleuritic chest pain | Cardiac disorders | Systematic Assessment |
|
| Kidney pain with near syncope | Hepatobiliary disorders | Systematic Assessment |
|
| Flu | Infections and infestations | Systematic Assessment |
|
| Bradycardia associated with dyspnea on exertion | Cardiac disorders | Systematic Assessment |
|
| Jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |