Paroxysmal Atrial Fibrillation
Conditions
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.
Interventions
DEVICERF Ablation with QDOT Micro
Subjects will be ablated using QDOT Micro catheter
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis | Up to 90 days (post initial and repeated ablation procedure) | 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. |
| 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 | Up to 7 days (post initial and repeated ablation procedure) | 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). |
| Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes | Day 91 to Day 365 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 PVs (entrance block) at the end of the procedure were reported |
| Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection | Up to 20 months | Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported. |
| Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection | Up to 20 months | Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported. |
| Percentage of Participants With Pulmonary Veins (PV) Touch-up | Up to 20 months | 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. |
| Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | Up to 20 months | Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported. |
| Number of Participants With Unanticipated Adverse Device Effects (UADEs) | Up to 20 months | Number of participants with UADEs were reported. |
| Percentage of Participants Who Underwent Repeat Ablation Procedures | Up to 20 months | Percentage of participants who underwent repeat ablation procedures were reported. |
| Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | Up to 20 months | Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported. |
| Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | Up to 20 months | Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported. |
| Percentage of Participants With 12-Month Single Procedure Success | Up to 12 months | 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. |
| Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | Up to 20 months | 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. |
| 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 serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and \>=31 days (late onset) of initial ablation were reported. |
| 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 191 |
| 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. | 92 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Discontinued before RF energy applied on inserted catheter | 2 | 1 |
| Overall Study | Due to a late entrance criteria deviation | 0 | 1 |
| Overall Study | Excluded before Catheter insertion | 14 | 5 |
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Variable Flow Arm: QDOT Micro Catheter | Total | Main Arm: QDOT Micro Catheter |
|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 9.75 | 64.0 years STANDARD_DEVIATION 10.22 | 63.5 years STANDARD_DEVIATION 10.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) White | 71 Participants | 237 Participants | 166 Participants |
| Sex: Female, Male Female | 38 Participants | 113 Participants | 75 Participants |
| Sex: Female, Male Male | 54 Participants | 170 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 177 | 1 / 87 |
| other Total, other adverse events | 58 / 177 | 19 / 87 |
| serious Total, serious adverse events | 32 / 177 | 14 / 87 |
Outcome results
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).
Time frame: Up to 7 days (post initial and repeated ablation procedure)
Population: The mITT analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | 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 | 3.6 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | 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 | 2.4 Percentage of Participants |
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.
Time frame: Up to 90 days (post initial and repeated ablation procedure)
Population: The modified Intent-to-treat (mITT) analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis | 0 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis | 0 Percentage of Participants |
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.
Time frame: Day 91 to Day 365
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes | 76.3 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes | 67.5 Percentage of Participants |
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.
Time frame: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
Population: The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major: 8 - 30 Days | 0 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM: >= 31 Days | 2 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM: 0-7 Days | 3 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor: 0-7 Days | 5 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major: >= 31 Days | 0 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor: 8-30 Days | 1 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM: 8-30 Days | 0 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor: >= 31 Days | 2 Participants |
| Main Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major: 0 - 7 Days | 3 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor: >= 31 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major: 0 - 7 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major: 8 - 30 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major: >= 31 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM: 0-7 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM: 8-30 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM: >= 31 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor: 0-7 Days | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor: 8-30 Days | 0 Participants |
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.
Time frame: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
Population: The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Arm: QDOT Micro Catheter | 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 | 0 - 7 Days | 8 Participants |
| Main Arm: QDOT Micro Catheter | 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 | 8 - 30 Days | 4 Participants |
| Main Arm: QDOT Micro Catheter | 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 | >= 31 Days | 25 Participants |
| Variable Flow Arm: QDOT Micro Catheter | 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 | 0 - 7 Days | 4 Participants |
| Variable Flow Arm: QDOT Micro Catheter | 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 | 8 - 30 Days | 3 Participants |
| Variable Flow Arm: QDOT Micro Catheter | 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 | >= 31 Days | 12 Participants |
Secondary
Number of Participants With Unanticipated Adverse Device Effects (UADEs)
Number of participants with UADEs were reported.
Time frame: Up to 20 months
Population: The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Number of Participants With Unanticipated Adverse Device Effects (UADEs) | 0 Participants |
| Variable Flow Arm: QDOT Micro Catheter | Number of Participants With Unanticipated Adverse Device Effects (UADEs) | 0 Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | 50.0 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | 63.6 Percentage of Participants |
Secondary
Percentage of Participants Who Underwent Repeat Ablation Procedures
Percentage of participants who underwent repeat ablation procedures were reported.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants Who Underwent Repeat Ablation Procedures | 10.8 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants Who Underwent Repeat Ablation Procedures | 13.4 Percentage of Participants |
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.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With 12-Month Single Procedure Success | 77.3 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With 12-Month Single Procedure Success | 72.4 Percentage of Participants |
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
Time frame: End of the Procedure (up to 20 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure | 100 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure | 100 Percentage of Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection | 42.7 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection | 31.7 Percentage of Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection | 57.3 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection | 68.3 Percentage of Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Pulmonary Veins (PV) Touch-up | 42.7 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With Pulmonary Veins (PV) Touch-up | 31.7 Percentage of Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | 100 Percentage of Participants |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | 100 Percentage of Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Anterior | 31.1 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Inferior | 28.9 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Posterior | 53.3 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Ridge | 42.2 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Superior | 44.4 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Anterior | 53.5 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Inferior | 37.2 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Posterior | 58.1 Percentage of Participants |
| Main Arm: QDOT Micro Catheter | Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Superior | 27.9 Percentage of Participants |
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.
Time frame: Up to 20 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Arm: QDOT Micro Catheter | Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | 27.4 Percentage of Targeted Veins |
| Variable Flow Arm: QDOT Micro Catheter | Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | 20.7 Percentage of Targeted Veins |