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REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation (RESET-VT)

Primary Purpose

Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Renal sympathetic denervation
VT ablation alone
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Tachycardia, Renal Sympathetic Denervation, Catheter Ablation, Cardioverter-Defibrillator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 18 years of age
  • Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)
  • Planned for catheter-based ablation of VT
  • All patients will have an existing ICD
  • 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:

  • MI or CVA within 30 days
  • Coronary Artery Bypass Graft (CABG) within 30 days of this procedure
  • Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)
  • GFR <30 ml/min (unless receiving dialysis)
  • Life expectancy <1 year for any medical condition
  • Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding)
  • Inability to give informed consent
  • Known pregnancy or positive -HCG within 7 days of procedure.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai
  • Homolka Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Renal sympathetic denervation

VT ablation alone

Arm Description

Catheter-based Renal Sympathetic Denervation Ablation Arm

No further therapy in addition to VT ablation

Outcomes

Primary Outcome Measures

Freedom From First Event Requiring ICD Therapy
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months

Secondary Outcome Measures

Number of Appropriate ICD Shocks for Ventricular Arrhythmia
An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Number of Inappropriate ICD Therapy
Number of inappropriate ICD therapy including both appropriate and inappropriate shocks
All ICD Therapies (Appropriate + Inappropriate)
cumulative ICD therapies including both appropriate and inappropriate shocks
Number of Participants With Mortality, ICD Storm and Incessant VT
Number of Participants with a composite of Mortality, ICD storm, and Incessant VT
Number of Participants With Hospitalizations for Cardiovascular Causes
Number of Episodes of Total VT Burden
Total VT burden (Number of episodes)
Number of Participants With All-Cause Mortality
Number of Participants With Occurrences of ICD Storm
The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.
Change in Brain Natriuretic Peptide (BNP)
Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.
Differences in BUN/Creatinine Measurements
Differences in BUN/creatinine measurements compared at 12 months to baseline.
Change in LV Size
LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline
Number of Procedure-related Adverse Events
Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction.
Changes in Mean Arterial Pressure
Change in mean arterial pressure
Number of Participants With Orthostatic Hypertension
Number of participants with other individual complication rates specifically orthostatic hypertension
Number of Participants With Other Complications
Other individual complication rates including, but not limited to MI and death
Number of Occurrences of Major Complication Rate
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)
Procedure Time
Renal Denervation Procedure time

Full Information

First Posted
March 19, 2013
Last Updated
April 8, 2020
Sponsor
Vivek Reddy
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1. Study Identification

Unique Protocol Identification Number
NCT01858194
Brief Title
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Acronym
RESET-VT
Official Title
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 recurrent VT following catheter ablation 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 and promoting ventricular remodeling. 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 prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
Detailed Description
The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Tachycardia, Renal Sympathetic Denervation, Catheter Ablation, Cardioverter-Defibrillator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal sympathetic denervation
Arm Type
Experimental
Arm Description
Catheter-based Renal Sympathetic Denervation Ablation Arm
Arm Title
VT ablation alone
Arm Type
Placebo Comparator
Arm Description
No further therapy in addition to VT ablation
Intervention Type
Device
Intervention Name(s)
Renal sympathetic denervation
Other Intervention Name(s)
Ablation Arm, Catheter-based Renal Sympathetic Denervation
Intervention Description
The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).
Intervention Type
Device
Intervention Name(s)
VT ablation alone
Intervention Description
Placebo arm will receive standard VT ablation using current techniques
Primary Outcome Measure Information:
Title
Freedom From First Event Requiring ICD Therapy
Description
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of Appropriate ICD Shocks for Ventricular Arrhythmia
Description
An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Time Frame
at 24 months
Title
Number of Inappropriate ICD Therapy
Description
Number of inappropriate ICD therapy including both appropriate and inappropriate shocks
Time Frame
at 24 months
Title
All ICD Therapies (Appropriate + Inappropriate)
Description
cumulative ICD therapies including both appropriate and inappropriate shocks
Time Frame
24 months
Title
Number of Participants With Mortality, ICD Storm and Incessant VT
Description
Number of Participants with a composite of Mortality, ICD storm, and Incessant VT
Time Frame
24 months
Title
Number of Participants With Hospitalizations for Cardiovascular Causes
Time Frame
24 months
Title
Number of Episodes of Total VT Burden
Description
Total VT burden (Number of episodes)
Time Frame
at 24 months
Title
Number of Participants With All-Cause Mortality
Time Frame
24 months
Title
Number of Participants With Occurrences of ICD Storm
Description
The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.
Time Frame
24 months
Title
Change in Brain Natriuretic Peptide (BNP)
Description
Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.
Time Frame
at baseline and at 12 months
Title
Differences in BUN/Creatinine Measurements
Description
Differences in BUN/creatinine measurements compared at 12 months to baseline.
Time Frame
baseline and 12 months
Title
Change in LV Size
Description
LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline
Time Frame
baseline and 12 months
Title
Number of Procedure-related Adverse Events
Description
Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction.
Time Frame
24 months
Title
Changes in Mean Arterial Pressure
Description
Change in mean arterial pressure
Time Frame
baseline and 24 months
Title
Number of Participants With Orthostatic Hypertension
Description
Number of participants with other individual complication rates specifically orthostatic hypertension
Time Frame
24 months
Title
Number of Participants With Other Complications
Description
Other individual complication rates including, but not limited to MI and death
Time Frame
at 24 months
Title
Number of Occurrences of Major Complication Rate
Description
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)
Time Frame
30 days
Title
Procedure Time
Description
Renal Denervation Procedure time
Time Frame
during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.) Planned for catheter-based ablation of VT All patients will have an existing ICD 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: MI or CVA within 30 days Coronary Artery Bypass Graft (CABG) within 30 days of this procedure Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis) GFR <30 ml/min (unless receiving dialysis) Life expectancy <1 year for any medical condition Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding) Inability to give informed consent Known pregnancy or positive -HCG within 7 days of procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Y Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Homolka Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

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