Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation (NEwTON AF)

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Treatment with IntellaNav StablePoint Ablation Catheter

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • A.o. Krankenhaus der Elisabethinen Linz
  • Vienna, Austria, 1190
    • Allgemeines Krankenhaus AKH
• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Ziekenhuis
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L8
      • Vancouver General Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
  • Quebec
    • Ste-Foy, Quebec, Canada, G1V 4G5
      • Institut Universitaire de cardiologie et de pneumologie de Quebec
• France
  • Paris, France, 75013
    • Hospital de la Pitie-Salpetriere
• Germany
  • Bernau, Germany, 16321
    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
• Hong Kong
  • Kowloon, Hong Kong
    • Queen Elizabeth Hospital
  • Shatin, Hong Kong, 999077
    • Prince of Wales Hospital
• Italy
  • Milano, Italy, 20132
    • Fondazione Centro San Raffaele
  • AN
    • Ancona, AN, Italy, 60126
      • Az. Osp. Lancisi
• Japan
  • Fukuoka-ken, Japan, 802-8555
    • Kokura Memorial Hospital
  • Kanagawa, Japan, 238-8558
    • Yokosuka Kyosai Hospital
• Monaco
  • Monaco, Monaco, 98000
    • Centre Hospitalier Princesse Grace
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Medisch Spectrum Twente
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Papworth Hospital
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital
  • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Lukes Idaho Cardiology Associates
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
    • West Des Moines, Iowa, United States, 50266
      • Mercy Hospital Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospitals
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's Duluth Clinic Regional Heart Center
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health
    • New York, New York, United States, 10021
      • Weill Cornell Medical University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1023
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19146
      • Bryn Mawr Medical Specialists
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Pasadena, Texas, United States, 77505
      • Orion Medical
    • Tyler, Texas, United States, 75702
      • Christus Trinity Mother Frances Health System
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Chippenham and Johnston-Willis Hospital (CJW)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.

2. Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation;
3. 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;
4. Subjects who are willing and capable of providing informed consent;
5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
6. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Subjects with New York Heart Association (NYHA) Class III or IV heart failure < 180 days prior to enrollment
2. Left atrial diameter > 5.0 cm or left atrial volume >50 ml/m² indexed based on the most recent echocardiography+
3. Left ventricular ejection fraction < 35% based on the most recent echocardiogram +
4. Continuous AF lasting longer than seven (7) days
5. Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
6. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
7. Subjects who have undergone any cardiac ablation or any surgery within 30 days prior to enrollment
8. Currently implanted with a pacemaker, ICD, CRT device, or an implanted arrhythmia loop recorder
9. Active systemic infection
10. Unstable angina or ongoing myocardial ischemia
11. Myocardial Infarction (MI) within 90 days prior to enrollment
12. Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++
13. Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI, coronary stenting procedures) ≤ 90 days prior to enrollment.
14. Severe valvular disease, including mechanical prosthetic mitral or tricuspid heart valves (patients with successful mitral valve repair allowed - annular ring constitutes repair);
15. Any prior history of documented cerebral infarct, TIA or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] <180 days prior to enrollment
16. 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)
17. Presence of left atrial appendage closure device
18. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
19. Subjects who, in the judgment of the investigator, have a life expectancy of less than two (2) years
20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion)
21. Amiodarone use within 60 days prior to enrollment
22. Any carotid stenting or endarterectomy
23. Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR <45 mL/min)
24. Known coagulopathy disorder (e.g. von Willebrand's disease, hemophilia)
25. Any known contraindication to an AF ablation
26. Any known contraindication for anticoagulation (e.g. patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation)
27. Vena cava embolic protection filter devices and/or known femoral thrombus that prevents catheter insertion from the femoral approach
28. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
29. Rheumatic Heart Disease
30. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
31. Subjects unable or unwilling to complete follow-up visits and examinations for the duration of the clinical study

32. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.

    • LVEF and LA diameters obtained ≤180 days prior to enrollment will be acceptable, unless a cardiac event has occurred (e.g. MI) between the date of the exam and the enrollment date. In this case, a new echocardiogram (trans-thoracic or trans-esophageal, or intracardiac echo) must be performed to confirm eligibility prior to performing ablation. If no recent (≤180 days prior to enrollment) echocardiogram is available at the time of the enrollment, a new echocardiogram must be performed either prior to enrolling the patient into the study or post-consent to confirm patient's eligibility prior to performing the ablation. For TTE, LA anteroposterior diameter measured by M-mode from the parasternal long-axis view will be used. If both LA diameter and volume are available and at least one of them meets the exclusion criteria, the subject is considered ineligible for the study.

      • The absence of thrombus must be confirmed by means of a trans-esophageal echocardiogram (TEE) within 48 hours prior to the procedure or Intracardiac Echography (ICE) during the procedure in subjects not adequately anticoagulated per Section 10.4.2. If a thrombus is observed, the subject no longer meets eligibility criteria and should be considered "Consent Ineligible".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Ablation Catheter; Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation	Device: Treatment with IntellaNav StablePoint Ablation Catheter; Patients will be treated with an ablation catheter; Other Names: IntellaNav StablePoint Catheter System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Primary Safety Events at 1-Month Post-Procedure	The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure.	Up to 30 Days
Rate of Primary Safety Events at 12-Months Post-Procedure	The primary safety endpoint at 12 months is defined as the safety event-free rate at 12 months post-procedure.	12 Months
Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure	The twelve-month effectiveness endpoint is defined as the event-free rate at twelve-month post-procedure.	12 Months
Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins	The primary effectiveness endpoint of acute procedural success is defined as the achievement of electrical isolation of all PVs using the IntellaNav StablePoint catheter only.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of AEs Through 12-Months Post-Procedure	Secondary Safety Endpoint - AE Rates	12 Months
Number of Patients With New or Increased Dose of AAD	Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD	12 Months
Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure	Secondary Effectiveness Endpoint 2 - Single Procedure Success defined as freedom from primary effectiveness failure without a repeat procedure	12 Months
Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence	Secondary Effectiveness Endpoint 3 - Symptomatic Recurrence: freedom from documented symptomatic AF/AT/AFL recurrence	12 Months
Rate of SAEs Through 12-Months Post-Procedure	Secondary Safety Endpoint - SAEs	12 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Gregory Michaud, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; StablePoint
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 92567361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No request for study data has been made at this time. However, Boston Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes