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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: RF Ablation with QDOT Micro


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Arm<br>Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator | Device: RF Ablation with QDOT Micro<br>* Subjects will be ablated using QDOT Micro catheter<br>|
| Experimental: Second Arm (variable flow)<br>subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator | Device: RF Ablation with QDOT Micro<br>* Subjects will be ablated using QDOT Micro catheter<br>|

What is the study measuring?
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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 |