Paroxysmal Atrial FibrillationNEwTON AFNCT04580914
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
A study testing Treatment with IntellaNav StablePoint Ablation Catheter in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 47 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Treatment with IntellaNav StablePoint Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 47 sitesin 13 countries
- Study dates
- 12 Apr 2021to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 34Show fewer
- 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
- Any known contraindication for anticoagulation (e.g. patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation)
- Vena cava embolic protection filter devices and/or known femoral thrombus that prevents catheter insertion from the femoral approach
- Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- Rheumatic Heart Disease
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
- Subjects unable or unwilling to complete follow-up visits and examinations for the duration of the clinical study
- 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".
Trial locations and contacts
47 sites in 13 countries.
47 sites in 13 countries
United States25 sites
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
Northwell Health
Bay Shore, New York, 11706
St. Lukes Idaho Cardiology Associates
Boise, Idaho, 83712
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, 19146
Bethesda North Hospital
Cincinnati, Ohio, 45242
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805
The Queen's Medical Center
Honolulu, Hawaii, 96813
St. Luke's Episcopal Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
University of Kansas Hospital
Kansas City, Kansas, 66160
Baptist Health Lexington
Lexington, Kentucky, 40503
Catholic Medical Center
Manchester, New Hampshire, 03102
Loyola University Medical Center
Maywood, Illinois, 60153
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802
Weill Cornell Medical University
New York, New York, 10021
AdventHealth Orlando
Orlando, Florida, 32803
Orion Medical
Pasadena, Texas, 77505
Chippenham and Johnston-Willis Hospital (CJW)
Richmond, Virginia, 23225
Sarasota Memorial Hospital
Sarasota, Florida, 34239
St. John's Hospital
Springfield, Illinois, 62769
Christus Trinity Mother Frances Health System
Tyler, Texas, 75702
Mercy Hospital Medical Center
West Des Moines, Iowa, 50266
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1023
Canada3 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-Foy, Quebec, G1V 4G5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L8
Taiwan3 sites
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, 11217
United Kingdom3 sites
Papworth Hospital
Cambridge, CB2 0AY
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Austria2 sites
A.o. Krankenhaus der Elisabethinen Linz
Linz, 4020
Allgemeines Krankenhaus AKH
Vienna, 1190
Hong Kong2 sites
Queen Elizabeth Hospital
Kowloon
Prince of Wales Hospital
Shatin, 999077
Italy2 sites
Az. Osp. Lancisi
Ancona, AN, 60126
Fondazione Centro San Raffaele
Milan, 20132
Japan2 sites
Kokura Memorial Hospital
Fukuoka-ken, 802-8555
Yokosuka Kyosai Hospital
Kanagawa, 238-8558
About this study
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Treatment with IntellaNav StablePoint Ablation Catheter
- Keywords
- Atrial Fibrillation, StablePoint, Paroxysmal Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with IntellaNav StablePoint Ablation CatheterDevice
Also called IntellaNav StablePoint Catheter System
Patients will be treated with an ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Ablation Catheter | Experimental | Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation Receives: Device: Treatment with IntellaNav StablePoint Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 Days
Secondary outcomes (5)
Rate of AEs Through 12-Months Post-Procedure
Secondary Safety Endpoint - AE Rates
Measured: 12 Months
Number of Patients With New or Increased Dose of AAD
Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD
Measured: 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
Measured: 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
Measured: 12 Months
Rate of SAEs Through 12-Months Post-Procedure
Secondary Safety Endpoint - SAEs
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start12 Apr 2021
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Michaud, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580914
- Sponsor's protocol ID
- 92567361
- Acronym
- NEwTON AF
- Status last verified
- Jan 2025
- First submitted
- 21 Sep 2020
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04580914
- Acronym / sponsor ID
- NEwTON AF / 92567361
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Fibrillation, StablePoint, Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Ablation Catheter | Experimental | Device: Treatment with IntellaNav StablePoint Ablation CatheterPatients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (34 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with IntellaNav StablePoint Ablation CatheterAlso: IntellaNav StablePoint Catheter SystemPatients will be treated with an ablation catheter | Device | Treatment with Ablation Catheter |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Rate of AEs Through 12-Months Post-Procedure
Time frame: 12 Months
Number of Patients With New or Increased Dose of AAD
Time frame: 12 Months
Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure
Time frame: 12 Months
Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence
Time frame: 12 Months
Rate of SAEs Through 12-Months Post-Procedure
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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
Related trials for Paroxysmal Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Michaud principal investigator
Massachusetts General Hospital
47 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with IntellaNav StablePoint Ablation Catheter in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 47 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada, Taiwan, United Kingdom, Austria and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Primary Safety Events at 1-Month Post-Procedure (time frame: Up to 30 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.