Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation

NCT02071511 | Terminated

• 1 other identifier: PV4286
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up

  Number of Patients with adverse events such as recurrens of Ventricular

  24 months

Secondary Outcomes (2)

• 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

Study Arms (2)

control group

ACTIVE COMPARATOR

Ablation of ventricular arrhythmias

Procedure: Ablation of ventricular arrhythmias

intervention group

SHAM COMPARATOR

Ablation of ventricular arrhythmias + renal denervation

Procedure: Ablation of ventricular arrhythmias + renal denervation

Interventions

Ablation of ventricular arrhythmias PROCEDURE

control group: Ablation of ventricular arrhythmias

control group

Ablation of ventricular arrhythmias + renal denervation PROCEDURE

Intervention group: Ablation of ventricular arrhythmias + renal denervation

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Ischemic cardiomyopathy
• NYHA II-III
• Recurrent ventricular tachycardia, ICD interventions (shock or ATP)
• Obtained written informed consent

You may not qualify if:

• Age \<18 years
• Previous VT ablation
• NYHA IV
• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Medtronic: collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Cardiomyopathies

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Willems, MD

  ASKLEPIOS St. Georg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 26, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)