Status:
COMPLETED
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Lead Sponsor:
Vivek Reddy
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 meth...
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 undergoi...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01858194
Start Date
March 1 2013
End Date
September 1 2017
Last Update
April 17 2020
Active Locations (2)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
Homolka Hospital
Prague, Czechia, 15030