Ventricular Catheter Ablation Study (VCAS)
A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Symptomatic Patients With Ventricular Arrhythmia
Field Medical
60 participants
Apr 12, 2024
INTERVENTIONAL
Conditions
Summary
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).
Eligibility
Inclusion Criteria5
- Signed patient informed consent form (ICF).
- Female and male participants between 18 and 80 years.
- For VCAS-I group, patients with VT meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD
- For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
- For VCAS-II, documentation of frequent PVCs by 24 hours Holter with \>15% PVC burden for asymptomatic patients and \>5% PVC burden for symptomatic patients within the last 60 days.
Exclusion Criteria22
- Body Mass Index \> 40.
- Pacemaker dependence.
- Ineligible for ablation according to Physician judgement (including but not limited to known to have protruding left ventricular thrombus or have implanted mechanical aortic and mitral valves).
- Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
- The presence of inferior vena cava embolic protection filter devices.
- Recent cardiac surgery (less than 2 months)
- NYHA Class IV.
- Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.
- Uncontrolled abnormal bleeding and/or clotting disorder.
- Contraindication to systemic or oral anticoagulation.
- Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to solid organ or hematologic transplant, or currently being evaluated for an organ transplant.
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea.
- Chronic renal insufficiency of eGFR\< 30 mL/min/1.73 m2.
- Active malignancy
- Untreated clinically significant infection.
- Life expectancy is less than one year.
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.
- Prohibitively distorted cardiac anatomy due to congenital heart disease.
- Had a recent percutaneous coronary intervention (\<1 month).
- Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study.
- Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
- Pregnancy or breastfeeding
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Interventions
Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.
Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06203262