| 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. | The modified Intent-to-treat (mITT) analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted. | Posted | | Number | | Percentage of Participants | | Up to 90 days (post initial and repeated ablation procedure) | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| 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). | The mITT analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted. | Posted | | Number | | Percentage of Participants | | Up to 7 days (post initial and repeated ablation procedure) | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
|
| 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. | The per-protocol (PP) analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | Day 91 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. |
|
| Secondary | Number of Participants With Unanticipated Adverse Device Effects (UADEs) | Number of participants with UADEs were reported. | The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered. | Posted | | Count of Participants | | Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered. | Posted | | Count of Participants | | Participants | | Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months) | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered. | Posted | | Count of Participants | | Participants | | Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months) | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter |
|
| 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 | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | End of the Procedure (up to 20 months) | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
|
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Targeted Veins | | Up to 20 months | Targeted Veins | Targeted Veins | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP set had participants who satisfied these criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) is number of participants analyzed for this endpoint and 'n' (number analyzed) is number of participants analyzed for specified categories. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. |
| |
| Secondary | Percentage of Participants Who Underwent Repeat Ablation Procedures | Percentage of participants who underwent repeat ablation procedures were reported. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure. | Posted | | Number | | Percentage of Participants | | Up to 20 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |
| 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. | The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. | Posted | | Number | | Percentage of Participants | | Up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Main Arm: QDOT Micro Catheter | Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. | | OG001 | Variable Flow Arm: QDOT Micro Catheter | Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. |
| |