Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
NCT ID: NCT04580914
Last Updated: 2025-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
321 participants
INTERVENTIONAL
2021-04-12
2023-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment with Ablation Catheter
Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation
Treatment with IntellaNav StablePoint Ablation Catheter
Patients will be treated with an ablation catheter
Interventions
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Treatment with IntellaNav StablePoint Ablation Catheter
Patients will be treated with an ablation catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
* 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".
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Michaud
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Arrhythmia Research Group
Jonesboro, Arkansas, United States
AdventHealth Orlando
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
St. Lukes Idaho Cardiology Associates
Boise, Idaho, United States
Loyola University Medical Center
Maywood, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Northwell Health
Bay Shore, New York, United States
Weill Cornell Medical University
New York, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Orion Medical
Pasadena, Texas, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, United States
Chippenham and Johnston-Willis Hospital (CJW)
Richmond, Virginia, United States
A.o. Krankenhaus der Elisabethinen Linz
Linz, , Austria
Allgemeines Krankenhaus AKH
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Vancouver General Hospital
Vancouver, British Columbia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-Foy, Quebec, Canada
Hospital de la Pitie-Salpetriere
Paris, , France
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, , Germany
Queen Elizabeth Hospital
Kowloon, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Az. Osp. Lancisi
Ancona, AN, Italy
Fondazione Centro San Raffaele
Milan, , Italy
Kokura Memorial Hospital
Fukuoka-ken, , Japan
Yokosuka Kyosai Hospital
Kanagawa, , Japan
Centre Hospitalier Princesse Grace
Monaco, , Monaco
Medisch Spectrum Twente
Amsterdam, , Netherlands
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Papworth Hospital
Cambridge, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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92567361
Identifier Type: -
Identifier Source: org_study_id
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