REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE)
Device: Boston Scientific Vessix Renal Denervation System
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients|
- Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]The primary endpoint of this study is the time to first event requiring ICD therapy or Incessant VT.(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.
- Appropriate ICD therapy assessed in the full intention-to-treat patient cohort [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
- Inappropriate ICD therapy [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
- Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]Number of Hospitalizations for Cardiovascular Causes
- Total VT burden [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]Total VT burden (Number of episodes)
- All-Cause Mortality [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]All-Cause Mortality
- occurrence of ICD storm [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
- BUN/creatinine measurements [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]Differences in BUN/creatinine measurements
- Procedure related adverse events [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
- Development of orthostatic hypotension [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]Development of orthostatic hypotension
- Major Complication Rate [ Time Frame: within first 30 days ] [ Designated as safety issue: No ]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)
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2021|
|Estimated Primary Completion Date:||October 2020 (Final data collection date for primary outcome measure)|
No Intervention: standard ICD implantation alone
These subjects will undergo standard ICD implantation alone (if not already present)
Experimental: Boston Scientific Vessix Renal Denervation System
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Device: 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
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Rationale for this Study
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 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
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.
After providing written consent the following data will be collected and examinations and tests performed:
- A physical examination
- Your blood pressure will be taken
- A review of your medical history and what medications you are taking
- A blood sample will be drawn for routine laboratory tests.
- Women who can have children will take a urine pregnancy test. The test must be negative for you to be in this study.
- A Transthoracic Echocardiogram (TTE)-a non-invasive test where a probe is placed on the chest wall and images are taken through the chest wall of the heart valves and heart muscle, that will measure the left ventricular size (heart wall thickness) and mitral inflow (flow of blood through the heart valve).
- An ICD interrogation (if you already have an ICD implanted) - a non-invasive test where a device is placed over the chest wall near your ICD, and data is transmitted wirelessly from your ICD to a laptop for your physician to review.
- An electrocardiogram (EKG) - a non-invasive test where several probes are placed on the chest wall that will measure electrical activity in your heart.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747837
|Contact: Vivek Reddy, MDfirstname.lastname@example.org|
|Contact: Betsy Ellsworth, MSN, ANPemail@example.com|
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|Orlando, Florida, United States, 32803|
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|United States, Massachusetts|
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