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

Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: RF Ablation with QDOT Micro

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
• Enrollment (Actual): 283
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Jacksonville, Florida, United States, 32204
      • Ascension St. Vincent's
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital Clinic
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Albert Einstein
    • New York, New York, United States, 10029
      • Mt. Sinai School of Medicine
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital
    • New York, New York, United States, 10016
      • NYU Langone
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Heart & Vascular
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Penn Health System
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Heart Health and Vascular
    • Austin, Texas, United States, 78758
      • St. David's - TCAR
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.	Up to 90 days (post initial and repeated ablation procedure)
Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding	A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).	Up to 7 days (post initial and repeated ablation procedure)
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes	Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: >2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.	Day 91 to Day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Unanticipated Adverse Device Effects (UADEs)	Number of participants with UADEs were reported.	Up to 20 months
Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure	Number of participants with serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation were reported.	Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset	Number of participants with bleeding complication (ISTH definitions): a) major, b) clinically relevant non-major and c) minor bleeding were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (>=) 2 grams per deciliter (g/dL), transfusion of >= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.	Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure	Percentage of participants with electrical isolation of PVs (entrance block) at the end of the procedure were reported	End of the Procedure (up to 20 months)
Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection	Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.	Up to 20 months
Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection	Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.	Up to 20 months
Percentage of Participants With Pulmonary Veins (PV) Touch-up	Percentage of participants with PV touch-up were reported. PV touch-up was defined as additional ablations being performed after first encirclement for targeted veins with acute reconnection.	Up to 20 months
Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins	Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.	Up to 20 months
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement	Percentage of participants with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). The review of all ablation targets for the 1 participant with RPV ridge entered by site resulted in reclassification to RPV superior. This outcome measure was planned to be analyzed for specified arm (main arm) only.	Up to 20 months
Percentage of Participants Who Underwent Repeat Ablation Procedures	Percentage of participants who underwent repeat ablation procedures were reported.	Up to 20 months
Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure	Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.	Up to 20 months
Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure	Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported.	Up to 20 months
Percentage of Participants With 12-Month Single Procedure Success	Percentage of participants with 12-month single procedure success were reported. The 12-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 seconds) during the evaluation period after a single ablation procedure.	Up to 12 months

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation; 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: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI_2017_07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes