Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Official title

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)

Overview

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

Interventions

• Device Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
  Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System

Primary outcome measures

• Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation [Time frame: Index ablation procedure through 12 months of follow up.]
• Incidence of Device- and Procedure-Related Serious Adverse Events Through 6 Months [Time frame: Index ablation procedure through 6 months of follow up.]

Secondary outcome measures (2)

• Secondary Endpoint: Quality of Life (AFEQT) [Time frame: Index ablation procedure through 12 months of follow up.]
• Secondary Endpoint: Quality of Life (EQ-5D) [Time frame: Index ablation procedure through 12 months follow up.]

Eligibility criteria

Inclusion criteria

• A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:

• a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
• at least 1 electrocardiographically documented episode within 12 months prior to enrollment
• Adults who are ≥18 and ≤80 years of age on the day of enrollment.
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

Exclusion criteria

• Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
• AF that required three (3) or more distinct cardioversions in the preceding 12 months.
• LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
• Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
• Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Presence of any pulmonary vein stents
• Known pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
• Moderate to severe aortic or mitral valve stenosis
• Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
• Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
• Unstable angina
• NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
• Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
• Rheumatic heart disease
• Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
• Contraindication to or unwillingness to use systemic anticoagulation
• Documented left atrial thrombus on imaging
• Active systemic infection or sepsis
• Hypertrophic cardiomyopathy
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
• Carotid stenting or endarterectomy
• History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
• Known allergies or hypersensitivities to adhesives
• Body mass index > 40 kg/m2
• Atrial myxoma
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Known drug or alcohol dependency
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.
• Treatment with Amiodarone within the 3 months prior to enrollment
• Amyloid heart disease (cardiac amyloidosis)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 24 centers

• Arrhythmia Research Group — Jonesboro
• Scripps Memorial Hospital — La Jolla
• Mercy General Hospital — Sacramento
• NCH Rooney Heart Institute — Naples
• Memorial Health University Medical Center — Savannah
• Northwestern University — Chicago
• Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) — Overland Park
• Massachusetts General Hospital — Boston
• … and 16 more centers

Identifiers

NCT: NCT07308847 · Horizon 360

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗