Back to resultsNon-vascular ICD Electrode Configuration Feasibility Study
Primary Purpose
Ventricular Arrythmia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Temporary implantation of defibrillation coils and pulse generator
Defibrillation following induction of VA (Configuration A first)
Defibrillation following induction of VA (Configuration B first)
Removal of defibrillation coils and pulse generator
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Arrythmia
Eligibility Criteria
Inclusion Criteria:
- Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines
- Patient must be at least 18 years of age
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
Exclusion Criteria:
- Pacemaker dependency
- Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
- Currently taking amiodarone or a Class IC antiarrhythmic drug
- Hypertrophic cardiomyopathy
- Anticipated high risk of stroke
- Anticipated high surgical risk or risk of infection
- Severe aortic stenosis
- Severe proximal three vessel coronary disease (over 70% in each vessel)
- Greater than 50% left main stem disease
- Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
- Medical conditions that preclude defibrillation testing
- Chronic renal insufficiency including patients on dialysis
- Subject is currently participating in another clinical investigation.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.
Sites / Locations
- Hospital Clínico Regional de Concepción
- Na Homolce Hospital
- Centro de Intervenciones Endovasculares y Cirugía Cardiovascular
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Configuration A first
Configuration B first
Arm Description
Subjects receive the test of Configuration A first and Configuration B second.
Subjects receive the test of Configuration B first and Configuration A second.
Outcomes
Primary Outcome Measures
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
Successful defibrillation is defined as termination of the induced VA to sinus rhythm or other non-life threatening ventricular or escape rhythm (such as atrial fibrillation) as determined by the implanting physician.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809701
Brief Title
Non-vascular ICD Electrode Configuration Feasibility Study
Official Title
Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
March 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Configuration A first
Arm Type
Experimental
Arm Description
Subjects receive the test of Configuration A first and Configuration B second.
Arm Title
Configuration B first
Arm Type
Experimental
Arm Description
Subjects receive the test of Configuration B first and Configuration A second.
Intervention Type
Procedure
Intervention Name(s)
Temporary implantation of defibrillation coils and pulse generator
Intervention Description
Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.
Intervention Type
Procedure
Intervention Name(s)
Defibrillation following induction of VA (Configuration A first)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Defibrillation following induction of VA (Configuration B first)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Removal of defibrillation coils and pulse generator
Intervention Description
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Primary Outcome Measure Information:
Title
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
Description
Successful defibrillation is defined as termination of the induced VA to sinus rhythm or other non-life threatening ventricular or escape rhythm (such as atrial fibrillation) as determined by the implanting physician.
Time Frame
During the study procedure
Other Pre-specified Outcome Measures:
Title
The number of acute adverse events associated with the temporary implant and defibrillation testing with the two NV-ICD electrode configurations under investigation
Description
Descriptive outcome summarizing possible acute adverse events with the temporary implant and defibrillation testing
Time Frame
Within 1 month of the study procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines
Patient must be at least 18 years of age
Subject must provide written informed consent prior to any clinical investigation-related procedure.
Exclusion Criteria:
Pacemaker dependency
Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
Currently taking amiodarone or a Class IC antiarrhythmic drug
Hypertrophic cardiomyopathy
Anticipated high risk of stroke
Anticipated high surgical risk or risk of infection
Severe aortic stenosis
Severe proximal three vessel coronary disease (over 70% in each vessel)
Greater than 50% left main stem disease
Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
Medical conditions that preclude defibrillation testing
Chronic renal insufficiency including patients on dialysis
Subject is currently participating in another clinical investigation.
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinoud E Knops, MD, PhD
Organizational Affiliation
Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Regional de Concepción
City
Concepción
State/Province
Bio Bio
Country
Chile
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Centro de Intervenciones Endovasculares y Cirugía Cardiovascular
City
Asunción
State/Province
Distrito Capital
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-vascular ICD Electrode Configuration Feasibility Study
We'll reach out to this number within 24 hrs