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Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (Q-FFICIENCY)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RF Ablation with QDOT Micro

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Main Arm

Second Arm (variable flow)

Arm Description

Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator

subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator

Outcomes

Primary Outcome Measures

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.

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).

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.

Secondary Outcome Measures

Number of Participants With Unanticipated Adverse Device Effects (UADEs)

Number of participants with UADEs were reported.

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.

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.

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

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.

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.

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.

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.

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.

Percentage of Participants Who Underwent Repeat Ablation Procedures

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

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

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

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.

Full Information

NCT ID

NCT03775512

First Posted

November 23, 2018

Last Updated

February 17, 2023

Sponsor

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03775512

Brief Title

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

Acronym

Q-FFICIENCY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

January 30, 2019 (Actual)

Primary Completion Date

February 17, 2022 (Actual)

Study Completion Date

February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

283 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Main Arm

Arm Type

Experimental

Arm Description

Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator

Arm Title

Second Arm (variable flow)

Arm Type

Experimental

Arm Description

subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator

Intervention Type

Device

Intervention Name(s)

RF Ablation with QDOT Micro

Intervention Description

Subjects will be ablated using QDOT Micro catheter

Primary Outcome Measure Information:

Title

Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis

Description

Time Frame

Up to 90 days (post initial and repeated ablation procedure)

Title

Description

Time Frame

Up to 7 days (post initial and repeated ablation procedure)

Title

Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes

Description

Time Frame

Day 91 to Day 365

Secondary Outcome Measure Information:

Title

Number of Participants With Unanticipated Adverse Device Effects (UADEs)

Description

Number of participants with UADEs were reported.

Time Frame

Up to 20 months

Title

Description

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)

Title

Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset

Description

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)

Title

Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure

Description

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)

Title

Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection

Description

Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.

Time Frame

Up to 20 months

Title

Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection

Description

Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.

Time Frame

Up to 20 months

Title

Percentage of Participants With Pulmonary Veins (PV) Touch-up

Description

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

Title

Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins

Description

Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.

Time Frame

Up to 20 months

Title

Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement

Description

Time Frame

Up to 20 months

Title

Percentage of Participants Who Underwent Repeat Ablation Procedures

Description

Percentage of participants who underwent repeat ablation procedures were reported.

Time Frame

Up to 20 months

Title

Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure

Description

Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.

Time Frame

Up to 20 months

Title

Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure

Description

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

Title

Percentage of Participants With 12-Month Single Procedure Success

Description

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: