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

Paroxysmal Atrial Fibrillation Clinical Trial

— Q-FFICIENCY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775512
• Other study ID #: BWI_2017_07
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: February 17, 2022

Study information

• Verified date: February 2023
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• RF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter

Locations

Country	Name	City	State
United States	Texas Heart Health and Vascular	Arlington	Texas
United States	JFK Medical Center	Atlantis	Florida
United States	St. David's - TCAR	Austin	Texas
United States	Grandview Medical Center	Birmingham	Alabama
United States	University of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center - Albert Einstein	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	Ascension St. Vincent's	Jacksonville	Florida
United States	Baptist Health	Lexington	Kentucky
United States	Abbott Northwestern Hospital Clinic	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Mt. Sinai School of Medicine	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	NYU Langone	New York	New York
United States	Florida Hospital	Orlando	Florida
United States	University of Penn Health System	Philadelphia	Pennsylvania
United States	WakeMed Heart & Vascular	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Number of Participants With Unanticipated Adverse Device Effects (UADEs)	Number of participants with UADEs were reported.	Up to 20 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Who Underwent Repeat Ablation Procedures	Percentage of participants who underwent repeat ablation procedures were reported.	Up to 20 months
Secondary	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
Secondary	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
Secondary	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