Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
Study Overview
Brief Summary
Study hypothesis:
With optimal medical therapy and repeated ablations, an additional renal denervation may have protective effects in terms of vegetative intrinsic activity and lead to a significant reduction in VT Burdens.
Study design:
Multicenter, randomized, prospective, single-blind clinical trial.
Detailed Description
Study protocol:
Catheter ablation of ventricular tachycardia versus combined catheter ablation of ventricular tachycardia and renal denervation.
A total of 50 patients with ventricular tachycardia treated with ICD shocks or ATP will be enrolled in this study. The randomization in the study is done before ablation.
For the ablation, an arterial access is required in both groups. During a 30 minutes waiting time which will apply to both groups, renal denervation will be performed.
In this period of time operators and staff will be blinded for the procedure, thereby they won't know if the patients will receive a renal denervation, in that way the investigators are avoiding a bias of future treatment of the patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Ischemic cardiomyopathy
- •NYHA II-III
- •Recurrent ventricular tachycardia, ICD interventions (shock or ATP)
- •Obtained written informed consent
Exclusion Criteria
- •Age <18 years
- •Previous VT ablation
- •Cardiopulmonary decompensation within the last 4 weeks
- •Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- •History of hemorrhagic diathesis or other coagulopathies
- •Contraindication for oral anticoagulation
- •Hyper- or hypothyroidism
- •Drug or chronic alcohol abuse
- •Has any condition that would make participation not be in the best interest of the subject
- •Incompliance
Outcomes
Primary Outcomes
Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
Time Frame: 24 months
Number of Patients with adverse events such as recurrens of Ventricular
Secondary Outcomes
- Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up(24 months)
- Number of periprocedural complications(24 months)