Repolarization and Activation Mapping in Ventricular Tachycardia Ablation: the REDEMPTION Study

NCT06765746 | Not Yet Recruiting

• 1 other identifier: REDEMPTION
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to prospectively evaluate a novel sinus rhythm mapping strategy for ventricular tachycardia (VT) ablation based on combined ventricular repolarization and activation (depolarization) mapping (REpolarization DEpolarization Mapping, REDEEM mapping). Furthermore, gathering clinical data on VT ablation with TactiFlex is also aimed.

Conditions

Ventricular Tachycardia Ablation

Keywords

ventricular tachycardia; EAM; Electroanatomical map; Substrate ablation; Catheter ablation

Outcome Measures

Primary Outcomes (1)

• Efficacy outcome

  Primary endpoint will be VT recurrence after ablation, defined as: appropriate ICD therapy or monomorphic VT recurrence.

  1 Year

Study Arms (1)

Patients undergoing ventricular tachycardia ablation

The intervention is standard of care. Ventricular tachycardia (VT) ablation will be performed following standard of care in all 40 patients in the arm. No experimental tool or comparator will be used. The study aims at evaluating a novel sinus rhythm mapping strategy. Furthermore, gathering clinical data on VT ablation with TactiFlex is also aimed. We aim at prospectively enrolling 40 patients in 1 year and to complete 1 year follow-up.

Procedure: Ventricular tachycardia ablation

Interventions

Ventricular tachycardia ablation PROCEDURE

All ventricular tachycardia (VT) ablation procedures will be performed under general anesthesia. An epicardial approach will be performed, if clinically needed, when a detailed endocardial mapping during VT fails to reveal the complete VT critical isthmus. In case of epicardial mapping, the pericardium will be accessed percutaneously using the method described by Sosa et al. VT activation mapping will be performed and the critical isthmus will be defined as the diastolic pathway. Ablation will be performed at 50 W (temperature limit of 43 °C) using an irrigated ablation catheter (TactiFlex, Abbott, MN). Ablation will be aimed at VT isthmus transection. Substrate modification will be added if the patient is still inducible or in the absence of any inducible/tolerated VT. Substrate ablation will be performed based on sinus rhythm mapping, aiming at non-inducibility of any VT. At the end of procedure, programmed ventricular stimulation will be repeated.

Patients undergoing ventricular tachycardia ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients undergoing VT ablation at Universitair Ziekenhuis Brussel (UZB), Brussels, Belgium will be prospectively enrolled if inclusion criteria will be fulfilled. Inclusion criteria will be: 1) VT ablation procedure; 2) High density endocardial or epicardial substrate EAM performed with the multipolar mapping catheter Advisor™ HD-Grid Mapping Catheter, (Abbott Labs, Abbott Park, IL, USA) in association with the EnsiteXTM Cardiac Mapping System, (Abbott Labs, Abbott Park, IL, USA); 3) Use of TactiFlexTM ablation catheter (Abbott Labs, Abbott Park, IL, USA). Exclusion criteria will be: 1) use of a different EAM mapping system. Clinical VT will be defined as a VT that occurs spontaneously based on analysis of 12-lead ECG QRS morphology, following current guidelines. Sustained VT will be defined as lasting more than 30 s

You may qualify if:

• Ventricular tachycardia ablation procedure;
• High density endocardial or epicardial substrate EAM performed with the multipolar mapping catheter Advisor™ HD-Grid Mapping Catheter, (Abbott Labs, Abbott Park, IL, USA) in association with the EnsiteXTM Cardiac Mapping System, (Abbott Labs, Abbott Park, IL, USA); 3) Use of TactiFlexTM ablation catheter (Abbott Labs, Abbott Park, IL, USA).

You may not qualify if:

• \) use of a different mapping system

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Luigi Pannone, MD - PhD

CONTACT

02 477 5660; luigi.pannone@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department: Heart Rhythm Management Centre, Postgraduate Course in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Universitair Ziekenhuis

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share