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The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.
Rationale for this Study
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, anti-arrhythmic drugs (AADs), and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of ICD shocks 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. 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 primary prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction. Also of note, there is data suggesting that RSDN may even decrease the rate of supraventricular arrhythmias such as atrial fibrillation. Thus, RESCUE will specifically evaluate the safety and efficacy of RSDN in the prevention of ICD therapy in patients with ventricular dysfunction who are to receive an ICD for either secondary prevention, or primary prevention if they have inducible VT by programmed ventricular stimulation at the time of ICD implantation.
Description of Procedures
Screening:
To take part in this study, you must meet all study requirements. The screening visit tests and procedures are done to see if you are eligible to be in the study. The study doctor will review these with you and let you know if you qualify. The study doctor will make a final decision about your possible study qualification.
Pre-randomization Procedures:
After providing written consent the following data will be collected and examinations and tests performed:
Randomization:
Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor will assess whether the renal arteries are suitable to receive catheter-based renal denervation. Once you agree to participate in this study, by signing this informed consent, and are it is determined that you are eligible to participate you will be randomized to one of two treatment groups immediately following the renal angiogram.
Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance (50%) of being placed in either group. This study design is single-blinded; you will not know ahead of time which group you will be in. Only your physician will know which group you are randomized to.
If you do not already have an ICD, you will undergo ICD placement as part of routine clinical care. You may undergo ICD placement up to 1 month (30 days) before randomization. An ICD (implantable cardioverter-defibrillator) is a small battery-powered electrical impulse generator which is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect abnormal heart beats (cardiac arrhythmia) and correct it by delivering a jolt of electricity.
The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery that deactivates the nerves that are linked to high blood pressure.
The second group (control group) will receive no further intervention after ICD implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard ICD implantation alone | No Intervention | These subjects will undergo standard ICD implantation alone (if not already present) | |
| Boston Scientific Vessix Renal Denervation System | Experimental | These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation. Ablation arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Vessix Renal Denervation System | Device | Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Event Requiring ICD Therapy or Incessant VT | The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Occurrences of Appropriate ICD Therapy | Number of Occurrences of Appropriate ICD therapy assessed in the full intention-to-treat patient cohort. An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | 24 months |
| Number of Occurrences of Inappropriate ICD Therapy |
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Inclusion Criteria:
≥ 18 years of age
Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, etc.)
Planned for ICD implantation for:
Accessibility of renal vasculature (determined by renal angiography)
Ability to understand the requirements of the study
Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States | ||
| Texas Cardiac |
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First enrollment on Oct 22, 2015.
Last enrollment on May 3, 2017 with last study visit date conducted on Jan 9, 2019,
50 participants consented, 2 were found ineligible due to irregular renal anatomy during the angiography and not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard ICD Implantation Alone | These subjects will undergo standard ICD implantation alone (if not already present) |
| FG001 | Boston Scientific Vessix Renal Denervation System | These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard ICD Implantation Alone | These subjects will undergo standard ICD implantation alone (if not already present) |
| BG001 | Boston Scientific Vessix Renal Denervation System |
| 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 | Time to First Event Requiring ICD Therapy or Incessant VT | The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | Posted | Mean | Standard Deviation | days | 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 | Standard ICD Implantation Alone | These subjects will undergo standard ICD implantation alone (if not already present) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Commack | Icahn School of Medicine at Mount Sinai | 212-824-8931 | sam.cammack@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 | Oct 20, 2016 | Jan 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003714 | Denervation |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
|
Number of occurrences of inappropriate shocks. Inappropriate ICD therapy are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing. |
| 24 months |
| Number of Hospitalizations for Cardiovascular Causes | Cumulative number of Hospitalizations for Cardiovascular Causes | 24 months |
| Number of Episodes of Total VT Burden | Cumulative Number of episodes of Total VT burden | 24 months |
| All-Cause Mortality | All-Cause Mortality | 24 months |
| Number of Occurrence of ICD Storm | The cumulative number of occurrences of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours | 24 months |
| BUN Measurements | Blood Urea Nitrogen (BUN) measurements | baseline, 6 months, 12 months, 24 months |
| Creatinine Measurements | Creatinine measurements | baseline, 6 months, 12 months, 24 months |
| Procedure Related Adverse Events | Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis. | 24 months |
| Number of Participants With Orthostatic Hypotension | Number of participants who developed of orthostatic hypotension | 24 months |
| Number of Participants With Major Complication | Number of Participants with Major Complication defined as death, stroke, myocardial infarction (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) | average 30 days |
| Austin |
| Texas |
| 78705 |
| United States |
| Na Homolce Hospital | Prague | 15030 | Czechia |
| Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology | Novosibirsk | Russia |
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
| 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 |
|
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|
| Secondary | Number of Occurrences of Appropriate ICD Therapy | Number of Occurrences of Appropriate ICD therapy assessed in the full intention-to-treat patient cohort. An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | Posted | Mean | Standard Deviation | Occurences | 24 months |
|
|
|
| Secondary | Number of Occurrences of Inappropriate ICD Therapy | Number of occurrences of inappropriate shocks. Inappropriate ICD therapy are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing. | Posted | Mean | Standard Deviation | Occurrences | 24 months |
|
|
|
| Secondary | Number of Hospitalizations for Cardiovascular Causes | Cumulative number of Hospitalizations for Cardiovascular Causes | cumulative number of hospitalizations | Posted | Number | hospitalizations | 24 months |
|
|
|
| Secondary | Number of Episodes of Total VT Burden | Cumulative Number of episodes of Total VT burden | Posted | Number | Episodes | 24 months |
|
|
|
| Secondary | All-Cause Mortality | All-Cause Mortality | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Occurrence of ICD Storm | The cumulative number of occurrences of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours | Posted | Number | occurences | 24 months |
|
|
|
| Secondary | BUN Measurements | Blood Urea Nitrogen (BUN) measurements | data only available for those participants who returned for respective study visits | Posted | Mean | Standard Deviation | mmol/L | baseline, 6 months, 12 months, 24 months |
|
|
|
| Secondary | Creatinine Measurements | Creatinine measurements | data only available for those participants who returned for respective study visits | Posted | Mean | Standard Deviation | µmol/L | baseline, 6 months, 12 months, 24 months |
|
|
|
| Secondary | Procedure Related Adverse Events | Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis. | Posted | Number | Events | 24 months |
|
|
|
| Secondary | Number of Participants With Orthostatic Hypotension | Number of participants who developed of orthostatic hypotension | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Participants With Major Complication | Number of Participants with Major Complication defined as death, stroke, myocardial infarction (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 | Count of Participants | Participants | average 30 days |
|
|
|
| 4 |
| 25 |
| 10 |
| 25 |
| 3 |
| 25 |
| EG001 | Boston Scientific Vessix Renal Denervation System | These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts | 4 | 23 | 11 | 23 | 6 | 23 |
| Bedsore of pocket ICD | Infections and infestations | Systematic Assessment |
|
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Collapse | General disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Emphysema Thoracalgia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Episode of Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Implantation of BIV IC | Surgical and medical procedures | Systematic Assessment |
|
| Ischemic Stroke | General disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Pleural Effusion | Cardiac disorders | Systematic Assessment |
|
| Pocket Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pocket Revision | Surgical and medical procedures | Systematic Assessment |
|
| Skin erosion on the place of ICD | Infections and infestations | Systematic Assessment |
|
| Stable exertional angina | Cardiac disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Dislocation of the Atrial Electrode | Surgical and medical procedures | Systematic Assessment |
|
| Groin Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Neoplasm of Left Kidney | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Puncture | Cardiac disorders | Systematic Assessment |
|
| Renal Artery Stenosis | Renal and urinary disorders | Systematic Assessment |
|
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Collapse | General disorders | Systematic Assessment |
|
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 6 months |
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| 12 months |
|
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| 24 months |
|
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| 6 months |
|
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| 12 months |
|
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| 24 months |
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