A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
Homolka Hospital
Prague, Czechia
Institute Klinicke a Experimentalni Mediciny
Prague, Czechia
Percentage of Subjects With a Primary Safety Event
The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 post-treatment assessment: transient ischemic attack; cerebrovascular accident; major bleeding; cardiac tamponade; pulmonary vein stenosis; severe pericarditis requiring extended hospitalization; myocardial infarction; diaphragmatic paralysis; atrio-esophageal fistula (through the Day 90 assessment) ; valvular damage; phrenic nerve palsy; intra-procedural device complications requiring open chest or heart surgery; vascular complications requiring surgical intervention; and death.
Time frame: 90 days
Number of Positive (Affirmative) Product Performance Responses
The primary acute product performance outcome is determined during the procedure and is defined as the following: * Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: * catheter delivery to the desired cardiac chambers * manipulation of catheter * completion of mapping procedure * safe removal of catheter from the subject * 3D electro-anatomical map creation and utility sufficient to aid diagnosis * Generation of acceptable acute therapeutic RF lesions
Time frame: Index ablation procedure
Percentage of Subjects Free From Documented Recurrence
A secondary product effectiveness outcome is freedom from documented recurrence of the treated arrhythmia through the Day 365 post-treatment follow-up visit. In AF subjects, this includes freedom from documented AF, atrial tachycardia (AT), or AFL.
Time frame: 12 months
Number of Patients With Durable Ablation Lesions at Remapping Procedure
* In AF subjects that are remapped, the number of pulmonary veins that remain isolated and the number of patients with all pulmonary veins isolated will be determined. * In all subjects that are remapped, the number of previously confirmed lines of block remaining isolated will be determined.
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Time frame: 3 months