An Initial Assessment of the Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial Arrhythmias
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Subjects With a Primary Safety Event
Study Overview
Brief Summary
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 and < 75 years.
- •Suitable candidate for catheter non-emergent mapping and ablation of atrial flutter or atrial fibrillation as follows:
- •Atrial Flutter defined as
- •o At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by EKG, 12 lead EKG, Holter or transtelephonic monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- •Atrial Fibrillation defined as
- •History of symptomatic paroxysmal and/or persistent atrial fibrillation within the past year documented by EKG AND
- •Failure of at least one class I-IV drug as evidenced by recurrent symptomatic AF, or intolerable to AAD.
- •Subject is able and willing to give informed consent.
- •Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.
Exclusion Criteria
- •Documented left atrial thrombus or another abnormality which precludes catheter introduction.
- •Documented ejection fraction (EF) < 40%.
- •Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]).
- •Unstable angina or ongoing myocardial ischemia.
- •Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
- •Congenital heart disease where the underlying abnormality increases the risk of the ablation.
- •Pulmonary hypertension (mean pulmonary artery pressure [mPAP] > 50 mmHg)
- •Enrollment in any other ongoing study protocol that would interfere with this study.
- •Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) < 29ml/min.
- •Active gastrointestinal (GI) bleeding.
- •Active infection or sepsis.
- •Short life expectancy (< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.
- •Significant anemia (defined as hemoglobin < 8.0 gr/dL).
- •Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within last 30 days.
- •Severe bleeding, clotting or thrombotic disorder.
- •Uncontrolled diabetes.
- •Women who are pregnant or are not willing to use contraception for the duration of the study.
- •Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume [FEV1] <1)
- •Prior stroke or TIA within the last 6 months.
- •Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.
- •Additional exclusion criteria for AF patients only
- •Left atrial diameter of > 55 mm (parasternal view).
- •Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
- •Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness >1.5cm.
- •Prior ablation or surgery for atrial fibrillation.
- •NYHA Class III or IV
Arms & Interventions
Subjects who are treated with the Sphere-9™ Catheter
Intervention: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System (Device)
Outcomes
Primary Outcomes
Number of Subjects With a Primary Safety Event
Time Frame: 90 days
The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 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.
Number of Positive (Affirmative) Product Performance Responses
Time Frame: Index ablation procedure
The primary 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
Secondary Outcomes
- Number of Subjects Free From Documented Recurrence(12 months)