Clinical trial NCT03775512: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis
timeFrame: Up to 90 days (post initial and repeated ablation procedure)
measure: 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
timeFrame: Up to 7 days (post initial and repeated ablation procedure)
measure: Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes
timeFrame: Day 91 to Day 365
Secondary outcomes:
measure: Number of Participants With Unanticipated Adverse Device Effects (UADEs)
timeFrame: Up to 20 months
measure: 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
timeFrame: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
measure: Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
timeFrame: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
measure: Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure
timeFrame: End of the Procedure (up to 20 months)
measure: Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection
timeFrame: Up to 20 months
measure: Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection
timeFrame: Up to 20 months
measure: Percentage of Participants With Pulmonary Veins (PV) Touch-up
timeFrame: Up to 20 months
measure: Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins
timeFrame: Up to 20 months
measure: Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
timeFrame: Up to 20 months
measure: Percentage of Participants Who Underwent Repeat Ablation Procedures
timeFrame: Up to 20 months
measure: Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure
timeFrame: Up to 20 months
measure: Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure
timeFrame: Up to 20 months
measure: Percentage of Participants With 12-Month Single Procedure Success
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Ascension St. Vincent's
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Lexington
country: United States
facility: Baptist Health
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center - Albert Einstein
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Heart & Vascular
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Penn Health System
state: Pennsylvania
city: Arlington
country: United States
facility: Texas Heart Health and Vascular
state: Texas
city: Austin
country: United States
facility: St. David's - TCAR
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Ohio State University
name: Emile Daoud
role: PRINCIPAL_INVESTIGATOR
affiliation: Grandview Medical Center
name: Jose Osorio
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania Health System
name: Francis Marchlinksi
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Medical Center
name: Michael Cutler
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Northwestern
name: Daniel Melby
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Miguel Valderabanno
role: PRINCIPAL_INVESTIGATOR
affiliation: AdventHealth
name: George Monir
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Heart Health and Vascular
name: Craig Delaughter
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital
name: Christopher Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Ascension St. Vincent's
name: Saumil Oza
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Ayman Hussein
role: PRINCIPAL_INVESTIGATOR
affiliation: JFK Hospital
name: Robert Fishel
role: PRINCIPAL_INVESTIGATOR
affiliation: VCU
name: Kenneth Ellenbogen
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital
name: Gery Tomassoni
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Tristram Bahnson
role: PRINCIPAL_INVESTIGATOR
affiliation: VUMC
name: Chris Ellis
role: PRINCIPAL_INVESTIGATOR
affiliation: Allegheny College
name: Emerson Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Loyola University
name: David Wilber
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass. General Hospital
name: Moussa Mansour
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Srinivas Dukkipati
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Hugh McElderry
role: PRINCIPAL_INVESTIGATOR
affiliation: Wakemed Heart and Vascular
name: Ashish Patel
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Medical Center
name: Larry Chinitz
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore
name: Luigi DiBiase
role: PRINCIPAL_INVESTIGATOR
References: