MedTrace Logo

Non-vascular ICD Electrode Configuration Feasibility Study

NCT04809701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-12

No results posted yet for this study

Summary

This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.

Conditions

  • Ventricular Arrythmia

Interventions

PROCEDURE

Temporary implantation of defibrillation coils and pulse generator

Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.

PROCEDURE

Defibrillation following induction of VA (Configuration A first)

Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration A. Then up to two defibrillation energies will be tested for Configuration B.

PROCEDURE

Defibrillation following induction of VA (Configuration B first)

Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration B. Then up to two defibrillation energies will be tested for Configuration A.

PROCEDURE

Removal of defibrillation coils and pulse generator

Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Reinoud E Knops, MD, PhD · Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2021-12-07
Completion
2022-03-24

Countries

  • Chile
  • Czechia
  • Paraguay

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809701 on ClinicalTrials.gov