Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation

NCT03775512 | Completed Results FDA Device

• 1 other identifier: BWI_2017_07
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 22

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Number of Participants With Unanticipated Adverse Device Effects (UADEs)

  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

  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

  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

  End of the Procedure (up to 20 months)

• Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection

  Up to 20 months

Study Arms (2)

Main Arm

EXPERIMENTAL

Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator

Device: RF Ablation with QDOT Micro

Second Arm (variable flow)

EXPERIMENTAL

subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator

Device: RF Ablation with QDOT Micro

Interventions

RF Ablation with QDOT Micro DEVICE

Subjects will be ablated using QDOT Micro catheter

Main Arm; Second Arm (variable flow)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (22)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

University of Alabama

Birmingham, Alabama, 35294, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Ascension St. Vincent's

Jacksonville, Florida, 32204, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Baptist Health

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Abbott Northwestern Hospital Clinic

Minneapolis, Minnesota, 55407, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Montefiore Medical Center - Albert Einstein

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

WakeMed Heart & Vascular

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Penn Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Heart Health and Vascular

Arlington, Texas, 76012, United States

Location

St. David's - TCAR

Austin, Texas, 78758, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 36752484 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Franchise Medical Manager
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• 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

  Massachusetts 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 14, 2018
• Study Start: January 30, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 16, 2023
• Results First Posted: March 16, 2023

Record last verified: 2023-02

Locations

US (22)