Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

Key facts

Study ID: NCT04580914
Run by: Boston Scientific Corporation
People needed: 321
Starts: 2021-04-12
Expected to finish: 2023-06-21
Last updated by the study team: 2025-01-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following:
a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes in the patient's history within the last 6 months prior to enrollment, and any electrocardiographically documented AF episode within 12 months prior to enrollment.
Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation;
Subjects refractory or intolerant to at least one class I or class III antiarrhythmic medication or contraindicated to any class I or class III medications;
Subjects who are willing and capable of providing informed consent;
Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

You may not qualify if…

Subjects with New York Heart Association (NYHA) Class III or IV heart failure < 180 days prior to enrollment
Left atrial diameter > 5.0 cm or left atrial volume >50 ml/m² indexed based on the most recent echocardiography+
Left ventricular ejection fraction < 35% based on the most recent echocardiogram +
Continuous AF lasting longer than seven (7) days
Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Subjects who have undergone any cardiac ablation or any surgery within 30 days prior to enrollment
Currently implanted with a pacemaker, ICD, CRT device, or an implanted arrhythmia loop recorder
Active systemic infection
Unstable angina or ongoing myocardial ischemia
Myocardial Infarction (MI) within 90 days prior to enrollment
Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++
Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI, coronary stenting procedures) ≤ 90 days prior to enrollment.
Severe valvular disease, including mechanical prosthetic mitral or tricuspid heart valves (patients with successful mitral valve repair allowed - annular ring constitutes repair);
Any prior history of documented cerebral infarct, TIA or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] <180 days prior to enrollment
Moderate or severe mitral stenosis (severity assessed on the most recent TTE ≤180 days prior to enrollment. Defined as pulmonary artery systolic pressure >30 mmHg)
Presence of left atrial appendage closure device
Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
Subjects who, in the judgment of the investigator, have a life expectancy of less than two (2) years
Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion)
Amiodarone use within 60 days prior to enrollment
Any carotid stenting or endarterectomy
Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR <45 mL/min)
Known coagulopathy disorder (e.g. von Willebrand's disease, hemophilia)
Any known contraindication to an AF ablation

Where it is running

Arrhythmia Research Group — Jonesboro, Arkansas, United States
AdventHealth Orlando — Orlando, Florida, United States
Sarasota Memorial Hospital — Sarasota, Florida, United States
The Queen's Medical Center — Honolulu, Hawaii, United States
St. Lukes Idaho Cardiology Associates — Boise, Idaho, United States
Loyola University Medical Center — Maywood, Illinois, United States
St. John's Hospital — Springfield, Illinois, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Mercy Hospital Medical Center — West Des Moines, Iowa, United States
University of Kansas Hospital — Kansas City, Kansas, United States
Baptist Health Lexington — Lexington, Kentucky, United States
University of Michigan Hospitals — Ann Arbor, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center — Duluth, Minnesota, United States
Catholic Medical Center — Manchester, New Hampshire, United States
Northwell Health — Bay Shore, New York, United States
Weill Cornell Medical University — New York, New York, United States
Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
Bethesda North Hospital — Cincinnati, Ohio, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Bryn Mawr Medical Specialists — Bryn Mawr, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
St. Luke's Episcopal Hospital — Houston, Texas, United States
Orion Medical — Pasadena, Texas, United States
Christus Trinity Mother Frances Health System — Tyler, Texas, United States
Chippenham and Johnston-Willis Hospital (CJW) — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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