REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/21/2018 |
| Start Date: | March 2013 |
| End Date: | September 1, 2017 |
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.
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.
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.
(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.
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.
We found this trial at
2
sites
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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