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New treatment option for Paroxysmal AF
Official title Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
ClinicalTrials.gov ID: NCT07308847
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or...
- 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.
You likely can't join if
- Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous...
- 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...
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any...
- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- Treatment with Amiodarone within the 3 months prior to enrollment
- Amyloid heart disease (cardiac amyloidosis)
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- La Jolla, California, United States
- Naples, Florida, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Fall River, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Paramus, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Austin, Texas, United States
- Falls Church, Virginia, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; La Jolla, California, United States; Naples, Florida, United States; Savannah, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.