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REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE)

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ClinicalTrials.gov Identifier: NCT01747837
Recruitment Status : Active, not recruiting
First Posted : December 12, 2012
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief Summary:
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 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 or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Boston Scientific Vessix Renal Denervation System Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
Actual Study Start Date : August 23, 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Ablation arm

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

Other Names:
  • Renal sympathetic denervation
  • Renal denervation
  • Denervation




Primary Outcome Measures :
  1. Time to first event requiring ICD therapy or Incessant VT [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    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 :
  1. 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 ]
    An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.

  2. Inappropriate ICD therapy [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    Inappropriate shocks are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.

  3. Number of Hospitalizations for Cardiovascular Causes [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    Number of Hospitalizations for Cardiovascular Causes

  4. Total VT burden [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    Total VT burden (Number of episodes)

  5. All-Cause Mortality [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    All-Cause Mortality

  6. occurrence of ICD storm [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours

  7. BUN/creatinine measurements [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    Differences in BUN/creatinine measurements

  8. Procedure related adverse events [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.

  9. Development of orthostatic hypotension [ Time Frame: at 1 month, 6 months, 12 months, 24 months, 36 months ]
    Development of orthostatic hypotension

  10. Major Complication Rate [ Time Frame: within first 30 days ]
    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)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • End stage renal failure on dialysis
  • Life expectancy <1 year for any medical condition
  • Known pregnancy or positive β-HCG within 7 days of procedure.
  • Coronary Artery Bypass Graft (CABG) within 30 days of the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747837


Locations
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Texas
Texas Cardiac
Austin, Texas, United States, 78705
Czechia
Na Homolce Hospital
Prague, Czechia, 15030
Russian Federation
Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Novosibirsk, Russian Federation
Sponsors and Collaborators
Vivek Reddy
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01747837     History of Changes
Other Study ID Numbers: 12-02-213
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Renal sympathetic denervation
Renal catheter ablation
Ventricular tachycardia

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