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

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ClinicalTrials.gov Identifier: NCT03775512
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date  ICMJE November 23, 2018
First Posted Date  ICMJE December 14, 2018
Last Update Posted Date December 1, 2020
Actual Study Start Date  ICMJE January 30, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Incidence of Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 12 months ]
Incidence of Unanticipated Adverse Device Effects (UADEs)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Official Title  ICMJE Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE Device: RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter
Study Arms  ICMJE
  • Experimental: Main Arm
    Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
    Intervention: Device: RF Ablation with QDOT Micro
  • Experimental: Second Arm (variable flow)
    subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator
    Intervention: Device: RF Ablation with QDOT Micro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
277
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE April 4, 2022
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03775512
Other Study ID Numbers  ICMJE BWI_2017_07
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biosense Webster, Inc.
Study Sponsor  ICMJE Biosense Webster, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Biosense Webster, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP