Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
NCT ID: NCT03775512
Last Updated: 2023-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
283 participants
INTERVENTIONAL
2019-01-30
2022-02-17
Brief Summary
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Detailed Description
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the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Main Arm
Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter
Second Arm (variable flow)
subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator
RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter
Interventions
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RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter
Eligibility Criteria
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Inclusion Criteria
* Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD.
* Age 18 years or older.
Exclusion Criteria
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days.
* Valve repair or replacement or presence of a prosthetic valve.
* CABG surgery within the past 6 months (180 days).
* Any carotid stenting or endarterectomy within the past 6 months.
* Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
* Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
* Documented LA size \> 50 mm.
* Documented LVEF \< 40%.
* Contraindication to anticoagulation (e.g., heparin).
* MI/PCI within the past 2 months.
* Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
* Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
* Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
* Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Emile Daoud
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Jose Osorio
Role: PRINCIPAL_INVESTIGATOR
Grandview Medical Center
Francis Marchlinksi
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Health System
Michael Cutler
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Andrea Natale
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Daniel Melby
Role: PRINCIPAL_INVESTIGATOR
Abbott Northwestern
Miguel Valderabanno
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
George Monir
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Craig Delaughter
Role: PRINCIPAL_INVESTIGATOR
Texas Heart Health and Vascular
Christopher Liu
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital
Saumil Oza
Role: PRINCIPAL_INVESTIGATOR
Ascension St. Vincent's
Ayman Hussein
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Robert Fishel
Role: PRINCIPAL_INVESTIGATOR
JFK Hospital
Kenneth Ellenbogen
Role: PRINCIPAL_INVESTIGATOR
VCU
Gery Tomassoni
Role: PRINCIPAL_INVESTIGATOR
Baptist Hospital
Tristram Bahnson
Role: PRINCIPAL_INVESTIGATOR
Duke University
Chris Ellis
Role: PRINCIPAL_INVESTIGATOR
VUMC
Emerson Liu
Role: PRINCIPAL_INVESTIGATOR
Allegheny College
David Wilber
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Moussa Mansour
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Srinivas Dukkipati
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Hugh McElderry
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Ashish Patel
Role: PRINCIPAL_INVESTIGATOR
Wakemed Heart and Vascular
Larry Chinitz
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Luigi DiBiase
Role: PRINCIPAL_INVESTIGATOR
Montefiore
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
University of Alabama
Birmingham, Alabama, United States
JFK Medical Center
Atlantis, Florida, United States
Ascension St. Vincent's
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Baptist Health
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Abbott Northwestern Hospital Clinic
Minneapolis, Minnesota, United States
NYU Langone
New York, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center - Albert Einstein
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
WakeMed Heart & Vascular
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Penn Health System
Philadelphia, Pennsylvania, United States
Texas Heart Health and Vascular
Arlington, Texas, United States
St. David's - TCAR
Austin, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Osorio J, Hussein AA, Delaughter MC, Monir G, Natale A, Dukkipati S, Oza S, Daoud E, Di Biase L, Mansour M, Fishel R, Valderrabano M, Ellenbogen K; Q-FFICIENCY Trial Investigators. Very High-Power Short-Duration, Temperature-Controlled Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: The Prospective Multicenter Q-FFICIENCY Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):468-480. doi: 10.1016/j.jacep.2022.10.019. Epub 2023 Jan 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BWI_2017_07
Identifier Type: -
Identifier Source: org_study_id
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