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

This study has suspended participant recruitment.
(Per DSMB, enrollment halted pending further review of safety data.)
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01747837
First received: November 1, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Ventricular Tachycardia
Device: Celsius Thermacool Catheter

Study Type: Interventional
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 Ventricular Tachyarrhythmias

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747837

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Czech Republic
Heart Center St. Anne's University Hospital
Brno, Czech Republic, 64691
Na Homolce Hospital
Prague, Czech Republic, 15030
Sponsors and Collaborators
Vivek Reddy
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01747837     History of Changes
Other Study ID Numbers: 12-02-213
Study First Received: November 1, 2012
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ethics Committee

Keywords provided by Mount Sinai School of Medicine:
Renal sympathetic denervation
Renal catheter ablation
Ventricular tachycardia

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014