Efficacy and Safety of Epicardial VT Ablation Using Contact Force Irrigated Tip Catheter - Pilot Study

NCT02072707 | Completed

• 1 other identifier: Arrit-Incor-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesized that combined endocardial and epicardial VT ablation using contact sensor irrigated catheter is safe and achieves a lower recurrence rate than endocardial only ablation in ischemic and non-ischemic patients, for this the investigators will randomize 20 patients in two groups, one with endocardial only ablation and other with combined endocardial and epicardial ablation.

Conditions

Tachycardia, Ventricular

Keywords

Ventricular Tachycardia; RF ablation; Epicardial Access; Contact Sensor Irrigated tip catheter

Outcome Measures

Primary Outcomes (1)

• Efficacy of epicardial ablation

  We will evaluate if the procedure was succeeded according to reinducibility of ventricular tachycardia. We consider success as follows: (1) Complete Success: prevention of induction of any VT following ablation; (2) Partial Success: prevention of induction of the clinical VT, remaining the induction of at least one non-clinical faster VT; (3) Failure: Remaining the induction of the clinical or initially induced VT.

  Programed ventricular stimulation performed 5 minutes after complete ablation

Secondary Outcomes (2)

• Safety of epicardial access

  24 hours after the procedure

• Safety of epicardial ablation using irrigated contact sensor catheter

  At the end of the procedure

Study Arms (2)

Epicardial VT ablation

ACTIVE COMPARATOR

Patients will underwent combined epicardial and endocardial mapping and ablation

Procedure: Epicardial VT ablation

Endocardial VT Ablation

ACTIVE COMPARATOR

Patients will underwent endocardial only VT mapping and ablation

Procedure: Endocardial VT Ablation

Interventions

Epicardial VT ablation PROCEDURE

Combined Epicardial and Endocardial VT Ablation

Epicardial VT ablation

Endocardial VT Ablation PROCEDURE

Endocardial Only VT ablation

Endocardial VT Ablation

Eligibility Criteria

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

You may qualify if:

• Patients with ischemic and non-ischemic cardiomyopathy and recurrent sustained monomorphic VT requiring cardioversion or antiarrhythmic drug administration with ≥4 episodes in the previous 6 months despite an ICD or antiarrhythmic drug therapy.
• Patients without ICD were eligible after 2 episodes of sustained VT.

You may not qualify if:

• Creatinine level \>2.5mg/dL
• LV ejection fraction \<10%
• NYHA Class IV
• Mobile thrombus on LV
• Absence of vascular access to the LV
• Life-expectancy of less than 12 months
• Previous open-chest cardiac surgical procedure
• Unstable angina; myocardial infarction in the last 2 months
• Severe aortic stenosis
• Severe mitral regurgitation secondary to leaflet or chordae rupture
• Pregnancy and age of less than 18 years old.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• Pisani CF, Romero J, Lara S, Hardy C, Chokr M, Sacilotto L, Wu TC, Darrieux F, Hachul D, Kalil-Filho R, Di Biase L, Scanavacca M. Efficacy and safety of combined endocardial/epicardial catheter ablation for ventricular tachycardia in Chagas disease: A randomized controlled study. Heart Rhythm. 2020 Sep;17(9):1510-1518. doi: 10.1016/j.hrthm.2020.02.009. Epub 2020 Feb 20.

  PMID: 32087356 RESULT

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

Study Officials

• Maurício Scanavacca, MD, PhD

  Instituto do coração - HC/FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Clinical Unit Director

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 26, 2014
• Study Start: April 1, 2014
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

BR (1)