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

Status: Active, not recruiting
Location: See all (47) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• 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.

Locations
United States
Arkansas
Arrhythmia Research Group
Jonesboro
Florida
AdventHealth Orlando
Orlando
Sarasota Memorial Hospital
Sarasota
Hawaii
The Queen's Medical Center
Honolulu
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Mercy Hospital Medical Center
West Des Moines
Idaho
St. Lukes Idaho Cardiology Associates
Boise
Illinois
Loyola University Medical Center
Maywood
St. John's Hospital
Springfield
Kansas
University of Kansas Hospital
Kansas City
Kentucky
Baptist Health Lexington
Lexington
Michigan
University of Michigan Hospitals
Ann Arbor
Minnesota
St. Mary's Duluth Clinic Regional Heart Center
Duluth
North Carolina
Wake Forest University School of Medicine
Winston-salem
New Hampshire
Catholic Medical Center
Manchester
New York
Northwell Health
Bay Shore
Weill Cornell Medical University
New York
Ohio
Bethesda North Hospital
Cincinnati
Cleveland Clinic Foundation
Cleveland
Pennsylvania
Bryn Mawr Medical Specialists
Bryn Mawr
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
St. Luke's Episcopal Hospital
Houston
Orion Medical
Pasadena
Christus Trinity Mother Frances Health System
Tyler
Virginia
Chippenham and Johnston-Willis Hospital (CJW)
Richmond
Other Locations
Austria
A.o. Krankenhaus der Elisabethinen Linz
Linz
Allgemeines Krankenhaus AKH
Vienna
Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst
Canada
Hamilton General Hospital
Hamilton
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-foy
Vancouver General Hospital
Vancouver
France
Hospital de la Pitie-Salpetriere
Paris
Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau
Hong Kong Special Administrative Region
Queen Elizabeth Hospital
Kowloon
Prince of Wales Hospital
Shatin, Hong Kong
Italy
Az. Osp. Lancisi
Ancona
Fondazione Centro San Raffaele
Milano
Japan
Kokura Memorial Hospital
Fukuoka-ken
Yokosuka Kyosai Hospital
Kanagawa-ken
Monaco
Centre Hospitalier Princesse Grace
Monaco
Netherlands
Medisch Spectrum Twente
Amsterdam
Taiwan
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Taipei Veterans General Hospital
Taipei
United Kingdom
Papworth Hospital
Cambridge
Liverpool Heart and Chest Hospital
Liverpool
Freeman Hospital
Newcastle-upon-tyne
Time Frame
Start Date: April 12, 2021
Estimated Completion Date: June 2023
Participants
Target number of participants: 299
Treatments
Experimental: Treatment with Ablation Catheter
Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation
Authors
Steven Bailin, Sheetal Chandhok, Jinu John, Dilip Mathew, Anish Amin, David Singh, Johan Aasbo, Jason Meyers, Jim Cheung, Yuet Wong Cheng, Jason Myers, Smit Vasaiwala, Suraj Kapa, Ziad Issa, Frank Pelosi, Matthew Bennett, Abdi Rasekh, Gregory Michaud, Jason Chinitz, Marcos Daccarett, Guru Mohanty, Karan Bhalla, Troy Rhodes, Stanislav Weiner, Christian Butter, Estelle Gandjbakhch, Decebal-Gabriel Latcu, Jamie Kim, David Hanes, Shaik Naushad, Juan Acosta, Naushad Shaik, Marshall Winner, Jean François Sarrazin, Moloy Das, Pascal Van Dessel, Helmut Puererfellner, Patrick Whalen, Antonio Dello Russo, Madhu Reddy, Li-Wei Lo, Tom De Potter, Thomas Callahan, Cheng-Hung Li, Manuela Cireddu, Kuan-Cheng Chang, Yasuaki Tanaka, Devi Nair, Günter Stix, Dhiraj Gupta, Claire Martin, Christopher Latanich, Joseph Yat Sun Chan
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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