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

January 14, 2025 updated by: Boston Scientific Corporation
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Québec
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Primary Safety Events at 1-Month Post-Procedure
Time Frame: Up to 30 Days
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
Time Frame: 12 Months
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
Time Frame: 12 Months
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
Time Frame: 30 Days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of AEs Through 12-Months Post-Procedure
Time Frame: 12 Months
Secondary Safety Endpoint - AE Rates
12 Months
Number of Patients With New or Increased Dose of AAD
Time Frame: 12 Months
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
Time Frame: 12 Months
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
Time Frame: 12 Months
Secondary Effectiveness Endpoint 3 - Symptomatic Recurrence: freedom from documented symptomatic AF/AT/AFL recurrence
12 Months
Rate of SAEs Through 12-Months Post-Procedure
Time Frame: 12 Months
Secondary Safety Endpoint - SAEs
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory Michaud, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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