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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Icahn School of Medicine at Mount Sinai
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01747837
First received: November 1, 2012
Last updated: June 28, 2016
Last verified: June 2016
  Purpose
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 Intervention
Ventricular Tachycardia
Device: Boston Scientific Vessix Renal Denervation System

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 Tachyarrhythmias in ICD Recipients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 462
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)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  • 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
  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

Contacts
Contact: Vivek Reddy, MD 212-241-7114 vivek.reddy@mountsinai.org
Contact: Betsy Ellsworth, MSN, ANP 212-824-8902 betsy.ellsworth@mountsinai.org

Locations
United States, Florida
Florida Hospital Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Leann Goodwin, RN    407-303-8059    leann.goodwin@flhosp.org   
Principal Investigator: Usman Siddiqui, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Carly Crocker       cacrocker@partners.org   
Principal Investigator: Jagmeet P Singh, MD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Betsy Ellsworth, MSN, ANP    212-824-8902    betsy.ellsworth@mountsinai.org   
Contact: Sam Cammack, MA, MPH    212 824-8931    sam.cammack@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
Principal Investigator: Srinivas Dukkipati, MD         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Debi Everidge, RN    843-792-2944    adamsde@musc.edu   
Principal Investigator: Frank Cuoco, MD         
United States, Texas
Texas Cardiac Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal, RN    512-458-9410    dscardinal@austinheartbeat.com   
Contact: Frankie Cruz    512-807-3150 ext 1838    fcruz@austinheartbeat.com   
Principal Investigator: Andrea Natale, MD         
Czech Republic
Heart Center St. Anne's University Hospital Not yet recruiting
Brno, Czech Republic, 64691
Contact: Veronika Bulková    00420725069195    veronica.bulkova@gmail.com   
Principal Investigator: Zdnek Starek, MD         
Na Homolce Hospital Recruiting
Prague, Czech Republic, 15030
Contact: Stepan Kralovec    00420 777671069    stepan.kralovec@gmail.com   
Principal Investigator: Petr Neuzil, MD, PhD         
Russian Federation
Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Contact: Marina Nikitenko    +7-913-720-06-79    m_nikitenko@meshalkin.ru   
Principal Investigator: Evgeny Pokushalov, MD         
Principal Investigator: Aleksandr Romanov, MD         
Sponsors and Collaborators
Vivek Reddy
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
  More Information

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 
Study First Received: November 1, 2012
Last Updated: June 28, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on August 28, 2016