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

• ClinicalTrials.gov Identifier: NCT03775512
• Recruitment Status: Completed
• First Posted: December 14, 2018
• Last Update Posted: April 19, 2022
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

Tracking Information

• First Submitted Date: November 23, 2018
• First Posted Date: December 14, 2018
• Last Update Posted Date: April 19, 2022
• Actual Study Start Date: January 30, 2019
• Actual Primary Completion Date: February 17, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Paroxysmal Atrial Fibrillation

Intervention

Device: RF Ablation with QDOT Micro

Subjects will be ablated using QDOT Micro catheter

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2022): 283
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 17, 2022
• Actual Primary Completion Date: February 17, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03775512
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Biosense Webster, Inc.
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Biosense Webster, Inc.
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• 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; The Methodist Hospital Research Institute
• 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: Ashish Patel; Wakemed Heart and Vascular
• Principal Investigator: Larry Chinitz; NYU Langone Medical Center
• Principal Investigator: Luigi DiBiase; Montefiore

• PRS Account: Biosense Webster, Inc.
• Verification Date: April 2022