Paroxysmal Atrial Fibrillation
Conditions
Brief summary
This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.
Interventions
Ablation and atrial mapping with the Globe Pulsed Field System
Sponsors
Kardium Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation * Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key
Exclusion criteria
* Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is sustained \>12 months) * Atrial fibrillation secondary to a reversible cause or of non-cardiac origin * History of thromboembolic events within the past six months * Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months * Any cardiac surgery within the previous six months * Prior left atrial ablation or surgical procedure * Presence of any pulmonary vein stents * Body mass index (BMI) \>40 kg/m\^2 * Left ventricular ejection fraction (LVEF) \<35% * Anterior-posterior left atrial (LA) diameter \>55mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month Treatment Success Rate | 12 months | The rate of 12-month treatment success following ablation procedure using the Globe Pulsed Field System. Treatment success is defined as freedom from treatment failure, where treatment failure includes: * Documented recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 seconds on Holter monitoring or equivalent during the effectiveness evaluation period, or by an episode documented on the entire recording of the 12-lead ECG (≥ 10 seconds) at the 12-month evaluation/visit. * Acute procedural failure * Direct current (DC) cardioversion for AF/AFL/AT during the effectiveness evaluation period * Redo ablation failure * Antiarrhythmic drugs (AADs) failure * Surgical treatment for AF/AFL/AT after the index procedure |
| Primary Safety Event Rate | 7 days | Rate of subjects presenting with one or more primary safety events up to and including 7 days after the index ablation procedure. Primary safety events comprise the following device- or procedure-related serious adverse events: * Death * Cardiac tamponade/perforation * Heart block * Major vascular access complication * Major bleeding * Myocardial infarction (MI) * Pericarditis requiring intervention * Pulmonary edema * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury resulting in gastroparesis * Atrio-esophageal fistula * Diaphragmatic paralysis/phrenic nerve injury * Severe pulmonary vein (PV) stenosis |
Contacts
CONTACTClinical Affairs
Outcome results
None listed