REnal SympathetiC Denervation to sUpprEss Ventricular Tachyarrhythmias (RESCUE-VT)

This study is currently recruiting participants.
Verified October 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01747837
First received: November 1, 2012
Last updated: October 24, 2013
Last verified: October 2013

November 1, 2012
October 24, 2013
October 2012
October 2015   (final data collection date for primary outcome measure)
  • Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 1 month ] [ 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.
  • Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 6 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.
  • Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 12 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.
  • Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 18 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.
  • Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 24 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.
Same as current
Complete list of historical versions of study NCT01747837 on ClinicalTrials.gov Archive Site
  • Appropriate ICD therapy assessed in the full intention-to-treat patient cohort [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    An Appropriate ICD therapy is defined as 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 6 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.
  • Appropriate ICD therapy assessed in the full intention-to-treat patient cohort [ Time Frame: at 12 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.
  • Appropriate ICD therapy assessed in the full intention-to-treat patient cohort [ Time Frame: at 18 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.
  • Appropriate ICD therapy assessed in the full intention-to-treat patient cohort [ Time Frame: at 24 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.
  • Appropriate ICD Shocks [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Appropriate shocks are shocks given by the ICD for ventricular tachycardia or ventricular fibrillation.
  • Appropriate ICD Shocks [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Appropriate shocks are shocks given by the ICD for ventricular tachycardia or ventricular fibrillation.
  • Appropriate ICD Shocks [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Appropriate shocks are shocks given by the ICD for ventricular tachycardia or ventricular fibrillation.
  • Appropriate ICD Shocks [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Appropriate shocks are shocks given by the ICD for ventricular tachycardia or ventricular fibrillation.
  • Appropriate ICD Shocks [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Appropriate shocks are shocks given by the ICD for ventricular tachycardia or ventricular fibrillation.
  • Inappropriate ICD therapy [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
  • Inappropriate ICD therapy [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
  • Inappropriate ICD therapy [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
  • Inappropriate ICD therapy [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
  • Inappropriate ICD therapy [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
  • VT occurring below the ICD rate cut-off [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    A composite of Mortality, ICD storm, and Incessant VT (VT occurring below the ICD rate cut-off)
  • VT occurring below the ICD rate cut-off [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    A composite of Mortality, ICD storm, and Incessant VT (VT occurring below the ICD rate cut-off)
  • VT occurring below the ICD rate cut-off [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    A composite of Mortality, ICD storm, and Incessant VT (VT occurring below the ICD rate cut-off)
  • VT occurring below the ICD rate cut-off [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    A composite of Mortality, ICD storm, and Incessant VT (VT occurring below the ICD rate cut-off)
  • VT occurring below the ICD rate cut-off [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    A composite of Mortality, ICD storm, and Incessant VT (VT occurring below the ICD rate cut-off)
  • Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Number of Hospitalizations for Cardiovascular Causes
  • Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Number of Hospitalizations for Cardiovascular Causes
  • Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 12 ] [ Designated as safety issue: No ]
    Number of Hospitalizations for Cardiovascular Causes
  • Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Number of Hospitalizations for Cardiovascular Causes
  • Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Number of Hospitalizations for Cardiovascular Causes
  • Total VT burden [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Total VT burden (Number of episodes)
  • Total VT burden [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Total VT burden (Number of episodes)
  • Total VT burden [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Total VT burden (Number of episodes)
  • Total VT burden [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Total VT burden (Number of episodes)
  • Total VT burden [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Total VT burden (Number of episodes)
  • All-Cause Mortality [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    All-Cause Mortality
  • All-Cause Mortality [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    All-Cause Mortality
  • All-Cause Mortality [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    All-Cause Mortality
  • All-Cause Mortality [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    All-Cause Mortality
  • All-Cause Mortality [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    All-Cause Mortality
  • occurrence of ICD storm [ Time Frame: at 1month ] [ Designated as safety issue: No ]
    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
  • occurrence of ICD storm [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
  • occurrence of ICD storm [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
  • occurrence of ICD storm [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
  • occurrence of ICD storm [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
  • blood hormone measurements [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Differences in blood hormone measurements (including norepinephrine, aldosterone, renin, and BNP)
  • blood hormone measurements [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Differences in blood hormone measurements (including norepinephrine, aldosterone, renin, and BNP)
  • blood hormone measurements [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Differences in blood hormone measurements (including norepinephrine, aldosterone, renin, and BNP)
  • blood hormone measurements [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Differences in blood hormone measurements (including norepinephrine, aldosterone, renin, and BNP)
  • blood hormone measurements [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Differences in blood hormone measurements (including norepinephrine, aldosterone, renin, and BNP)
  • BUN/creatinine measurements [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Differences in BUN/creatinine measurements
  • BUN/creatinine measurements [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Differences in BUN/creatinine measurements
  • BUN/creatinine measurements [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Differences in BUN/creatinine measurements
  • BUN/creatinine measurements [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Differences in BUN/creatinine measurements
  • BUN/creatinine measurements [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Differences in BUN/creatinine measurements
  • Differences in cardiac parameters [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Differences in cardiac parameters, including LV size (septal and free wall thickness) and mitral inflow (E&A velocity), as measured by trans-thoracic echocardiography.
  • Differences in cardiac parameters [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Differences in cardiac parameters, including LV size (septal and free wall thickness) and mitral inflow (E&A velocity), as measured by trans-thoracic echocardiography.
  • Differences in cardiac parameters [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Differences in cardiac parameters, including LV size (septal and free wall thickness) and mitral inflow (E&A velocity), as measured by trans-thoracic echocardiography.
  • Differences in cardiac parameters [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Differences in cardiac parameters, including LV size (septal and free wall thickness) and mitral inflow (E&A velocity), as measured by trans-thoracic echocardiography.
  • Differences in cardiac parameters [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Differences in cardiac parameters, including LV size (septal and free wall thickness) and mitral inflow (E&A velocity), as measured by trans-thoracic echocardiography.
  • Procedure related adverse events [ Time Frame: at 1 month ] [ Designated as safety issue: Yes ]
    Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
  • Procedure related adverse events [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
    Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
  • Procedure related adverse events [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
    Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
  • Procedure related adverse events [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]
    Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
  • Procedure related adverse events [ Time Frame: at 24 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 ] [ Designated as safety issue: No ]
    Development of orthostatic hypotension
  • Development of orthostatic hypotension [ Time Frame: at 6 month ] [ Designated as safety issue: No ]
    Development of orthostatic hypotension
  • Development of orthostatic hypotension [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Development of orthostatic hypotension
  • Development of orthostatic hypotension [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Development of orthostatic hypotension
  • Development of orthostatic hypotension [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Development of orthostatic hypotension
  • complication rates [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Other individual complication rates including, but not limited to MI and death
  • complication rates [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Other individual complication rates including, but not limited to MI and death
  • complication rates [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Other individual complication rates including, but not limited to MI and death
  • complication rates [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    Other individual complication rates including, but not limited to MI and death
  • complication rates [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Other individual complication rates including, but not limited to MI and death
  • 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)
Same as current
Not Provided
Not Provided
 
REnal SympathetiC Denervation to sUpprEss Ventricular Tachyarrhythmias
REnal SympathetiC Denervation to sUpprEss Ventricular Tachyarrhythmias

The goal 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 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

This study 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:

  • 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Ventricular Tachycardia
Device: Celsius Thermacool Catheter

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.

Celsius Thermacool Catheter, Biosense Webster Inc, Diamond Bar, California

Other Names:
  • Renal sympathetic denervation
  • Renal denervation
  • Denervation
  • No Intervention: standard ICD implantation alone
    These subjects will undergo standard ICD implantation alone (if not already present)
  • Experimental: Celsius Thermacool Catheter

    These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.

    Ablation arm

    Intervention: Device: Celsius Thermacool Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 18 years of age
  • Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, etc.)
  • Planned for ICD implantation for:

    • i. Secondary prevention (eg: VT/VF arrest, sustained VT, syncope/inducible VT)
    • ii. Primary prevention + inducible MMVT during induction via ICD lead testing
  • 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:

  • Patient taking a Class I or III antiarrhythmic drug.
  • Planned to undergo a cardiac VT ablation procedure
  • NYHA Class IV Congestive Heart Failure
  • MI within 30 days
  • Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
  • Baseline orthostatic hypotension
  • GFR < 45 ml/min (unless receiving dialysis)
  • Life expectancy <1 year for any medical condition
Both
18 Years to 85 Years
No
Contact: Vivek Reddy, MD 212-241-7114 vivek.reddy@mountsinai.org
Contact: Betsy Ellsworth, MSN, ANP 212-824-8902 betsy.ellsworth@mountsinai.org
United States,   Czech Republic
 
NCT01747837
12-02-213
Yes
Vivek Reddy, Mount Sinai School of Medicine
Vivek Reddy
Not Provided
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP