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

Paroxysmal Atrial Fibrillation Clinical Trial

— NEwTON AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580914
• Other study ID #: 92567361
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: June 21, 2023

Study information

• Verified date: July 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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".

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Treatment with IntellaNav StablePoint Ablation Catheter
Patients will be treated with an ablation catheter

Locations

Country	Name	City	State
Austria	A.o. Krankenhaus der Elisabethinen Linz	Linz
Austria	Allgemeines Krankenhaus AKH	Vienna
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Institut universitaire de Cardiologie et de Pneumologie de Quebec	Ste-Foy	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
France	Hospital de la Pitie-Salpetriere	Paris
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Hong Kong	Queen Elizabeth Hospital	Kowloon
Hong Kong	Prince of Wales Hospital	Shatin
Italy	Az. Osp. Lancisi	Ancona	AN
Italy	Fondazione Centro San Raffaele	Milano
Japan	Kokura Memorial Hospital	Fukuoka-ken
Japan	Yokosuka Kyosai Hospital	Kanagawa
Monaco	Centre Hospitalier Princesse Grace	Monaco
Netherlands	Medisch Spectrum Twente	Amsterdam
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Freeman Hospital	Newcastle-upon-Tyne
United States	University of Michigan Hospitals	Ann Arbor	Michigan
United States	Northwell Health	Bay Shore	New York
United States	St. Lukes Idaho Cardiology Associates	Boise	Idaho
United States	Bryn Mawr Medical Specialists	Bryn Mawr	Pennsylvania
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	St. Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Loyola University Medical Center	Maywood	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medical University	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Orion Medical	Pasadena	Texas
United States	Chippenham and Johnston-Willis Hospital (CJW)	Richmond	Virginia
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	St. John's Hospital	Springfield	Illinois
United States	Christus Trinity Mother Frances Health System	Tyler	Texas
United States	Mercy Hospital Medical Center	West Des Moines	Iowa
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Hong Kong,  Italy,  Japan,  Monaco,  Netherlands,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from Treatment Failure at 6-Months Post-Procedure	The primary effectiveness endpoint at 6 months is defined as event-free rate, which will be evaluated at a six-month interim analysis.	Up to 6 Months
Primary	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
Primary	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
Primary	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	Rate of SAEs and AEs through 12-Months Post-Procedure	Secondary Safety Endpoint - SAE and AE Rates	12 Months
Secondary	Number of patients with New or Increased Dose of AAD	Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD	12 Months
Secondary	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
Secondary	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