Clinical trial NCT04580914: Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
Official title: Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
StablePoint
Paroxysmal Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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".

Primary outcomes:
measure: Rate of Primary Safety Events at 1-Month Post-Procedure
timeFrame: Up to 30 Days
measure: Rate of Primary Safety Events at 12-Months Post-Procedure
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure
timeFrame: 12 Months
measure: Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins
timeFrame: 30 Days
Secondary outcomes:
measure: Rate of AEs Through 12-Months Post-Procedure
timeFrame: 12 Months
measure: Number of Patients With New or Increased Dose of AAD
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence
timeFrame: 12 Months
measure: Rate of SAEs Through 12-Months Post-Procedure
timeFrame: 12 Months
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Boise
country: United States
facility: St. Lukes Idaho Cardiology Associates
state: Idaho
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Bay Shore
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Pasadena
country: United States
facility: Orion Medical
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Richmond
country: United States
facility: Chippenham and Johnston-Willis Hospital (CJW)
state: Virginia
city: Linz
country: Austria
facility: A.o. Krankenhaus der Elisabethinen Linz
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Ste-Foy
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Paris
country: France
facility: Hospital de la Pitie-Salpetriere
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Ancona
country: Italy
facility: Az. Osp. Lancisi
state: AN
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele
city: Fukuoka-ken
country: Japan
facility: Kokura Memorial Hospital
city: Kanagawa
country: Japan
facility: Yokosuka Kyosai Hospital
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
city: Amsterdam
country: Netherlands
facility: Medisch Spectrum Twente
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Gregory Michaud
role: PRINCIPAL_INVESTIGATOR
References: