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Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (Q-FFICIENCY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775512
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: RF Ablation with QDOT Micro Not Applicable

Detailed Description:

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 277 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : April 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Main Arm
Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
Device: RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter

Experimental: Second Arm (variable flow)
subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator
Device: RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter




Primary Outcome Measures :
  1. Acute Safety: Incidence of early onset PAEs [ Time Frame: 7 days of the procedure ]

    Incidence of early onset primary adverse events (PAE) related to the device or procedure. Occurrence of Primary AEs within 7 days of an ablation procedure.

    Primary adverse events include the following conditions

    • Death
    • Atrio-esophageal fistula
    • Cardiac Tamponade/Perforation
    • Myocardial infarction (MI)
    • Stroke / Cerebrovascular accident (CVA)
    • Thromboembolism
    • Transient Ischemic Attack
    • Phrenic Nerve Injury/Diaphragmatic paralysis
    • Heart block
    • PV stenosis
    • Pulmonary edema (Respiratory Insufficiency)
    • Vagal Nerve Injury
    • Pericarditis
    • Major vascular access complication / bleeding

  2. Freedom from atrial tachyarrhythmias recurrence [ Time Frame: 3- 12 months ]
    The primary effectiveness endpoint is defined as the freedom from documented atrial fibrillation, atrial flutter and atrial tachycardia recurrence.


Secondary Outcome Measures :
  1. Incidence of Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 12 months ]
    Incidence of Unanticipated Adverse Device Effects (UADEs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.
  • 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.

Key Exclusion Criteria:

  • Previous surgical or catheter ablation for atrial fibrillation.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775512


Locations
Show Show 22 study locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
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Principal Investigator: Emile Daoud Ohio State University
Principal Investigator: Jose Osorio Grandview Medical Center
Principal Investigator: Francis Marchlinksi University of Pennsylvania Health System
Principal Investigator: Michael Cutler Intermountain Medical Center
Principal Investigator: Andrea Natale Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Daniel Melby Abbott Northwestern
Principal Investigator: Miguel Valderabanno Houston Methodist
Principal Investigator: George Monir AdventHealth
Principal Investigator: Craig Delaughter Texas Heart Health and Vascular
Principal Investigator: Christopher Liu New York Presbyterian Hospital
Principal Investigator: Saumil Oza Ascension St. Vincent's
Principal Investigator: Ayman Hussein The Cleveland Clinic
Principal Investigator: Robert Fishel JFK Hospital
Principal Investigator: Kenneth Ellenbogen VCU
Principal Investigator: Gery Tomassoni Baptist Hospital
Principal Investigator: Tristram Bahnson Duke University
Principal Investigator: Chris Ellis VUMC
Principal Investigator: Emerson Liu Allegheny College
Principal Investigator: David Wilber Loyola University
Principal Investigator: Moussa Mansour Mass. General Hospital
Principal Investigator: Srinivas Dukkipati Icahn School of Medicine at Mount Sinai
Principal Investigator: Hugh McElderry University of Alabama at Birmingham
Principal Investigator: Patrick Hranitzky Wakemed Heart and Vascular
Principal Investigator: Larry Chinitz NYU Langone Medical Center
Principal Investigator: Luigi DiBiase Montefiore
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT03775512    
Other Study ID Numbers: BWI_2017_07
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes