Non-vascular ICD Electrode Configuration Feasibility Study
NCT ID: NCT04809701
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2021-03-22
2022-03-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acute Feasibility Investigation of a New S-ICD Electrode
NCT03802110
Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)
NCT02027883
Extravascular ICD Pilot Study
NCT03608670
Effect of Right Ventricular Lead Position on Defibrillation Threshold
NCT02844127
Acute Defibrillation Study
NCT02227121
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Configuration A first
Subjects receive the test of Configuration A first and Configuration B second.
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.
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.
Removal of defibrillation coils and pulse generator
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Configuration B first
Subjects receive the test of Configuration B first and Configuration A second.
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.
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.
Removal of defibrillation coils and pulse generator
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Removal of defibrillation coils and pulse generator
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient must be at least 18 years of age
3. Subject must provide written informed consent prior to any clinical investigation-related procedure.
Exclusion Criteria
2. Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
3. Currently taking amiodarone or a Class IC antiarrhythmic drug
4. Hypertrophic cardiomyopathy
5. Anticipated high risk of stroke
6. Anticipated high surgical risk or risk of infection
7. Severe aortic stenosis
8. Severe proximal three vessel coronary disease (over 70% in each vessel)
9. Greater than 50% left main stem disease
10. Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
11. Medical conditions that preclude defibrillation testing
12. Chronic renal insufficiency including patients on dialysis
13. Subject is currently participating in another clinical investigation.
14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
15. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Reinoud E Knops, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínico Regional de Concepción
Concepción, Bio Bio, Chile
Na Homolce Hospital
Prague, , Czechia
Centro de Intervenciones Endovasculares y Cirugía Cardiovascular
Asunción, Asunción, Paraguay
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABT-CIP-10369
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.