Paroxysmal Atrial FibrillationQ-FFICIENCYNCT03775512

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

A study testing RF Ablation with QDOT Micro in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Paroxysmal Atrial Fibrillation
What is being tested?: RF Ablation with QDOT Micro
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 283 participants
Where: 22 sitesUnited States
Study dates: 30 Jan 2019to 17 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Texas Heart Health and Vascular
Arlington, Texas, 76012
JFK Medical Center
Atlantis, Florida, 33462
St. David's - TCAR
Austin, Texas, 78758
Grandview Medical Center
Birmingham, Alabama, 35243
University of Alabama
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27705
Houston Methodist Hospital
Houston, Texas, 77030
Ascension St. Vincent's
Jacksonville, Florida, 32204
Baptist Health
Lexington, Kentucky, 40503
Abbott Northwestern Hospital Clinic
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84107
NYU Langone
New York, New York, 10016
Mt. Sinai School of Medicine
New York, New York, 10029
New York Presbyterian Hospital
New York, New York, 10065
Florida Hospital
Orlando, Florida, 32803
University of Penn Health System
Philadelphia, Pennsylvania, 19104
WakeMed Heart & Vascular
Raleigh, North Carolina, 27610
Virginia Commonwealth University
Richmond, Virginia, 23298
Montefiore Medical Center - Albert Einstein
The Bronx, New York, 10467

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Paroxysmal Atrial Fibrillation
Being tested: RF Ablation with QDOT Micro
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RF Ablation with QDOT MicroDevice
Subjects will be ablated using QDOT Micro catheter

Study groups in NCT03775512
Study group	Role	What they receive
Main Arm	Experimental	Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator Receives: Device: RF Ablation with QDOT Micro
Second Arm (variable flow)	Experimental	subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator Receives: Device: RF Ablation with QDOT Micro

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: Day 91 to Day 365

Secondary outcomes (13)

Number of Participants With Unanticipated Adverse Device Effects (UADEs)
Number of participants with UADEs were reported.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 20 months
Percentage of Participants Who Underwent Repeat Ablation Procedures
Percentage of participants who underwent repeat ablation procedures were reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 201917 Feb 2022

First posted14 Dec 2018
Study start30 Jan 2019
Primary completion17 Feb 2022
Study completion17 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 283 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03775512
Sponsor's protocol ID: BWI_2017_07
Acronym: Q-FFICIENCY
Status last verified: Feb 2023
First submitted: 23 Nov 2018
Last updated: 16 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Osorio J, Hussein AA, Delaughter MC, Monir G, Natale A, Dukkipati S, Oza S, Daoud E, Di Biase L, Mansour M, Fishel R, Valderrabano M, Ellenbogen K; Q-FFICIENCY Trial Investigators. Very High-Power Short-Duration, Temperature-Controlled Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: The Prospective Multicenter Q-FFICIENCY Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):468-480. doi: 10.1016/j.jacep.2022.10.019. Epub 2023 Jan 18.
PubMed 36752484

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation

All Paroxysmal Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF
ClinicalTrials.gov ID: NCT03775512
Acronym / sponsor ID: Q-FFICIENCY / BWI_2017_07
Conditions: Paroxysmal Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 283 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 30 Jan 2019 (actual)
Primary completion: 17 Feb 2022 (actual)
Study completion: 17 Feb 2022 (actual)
First posted: 14 Dec 2018 (actual)
Results: Posted 16 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Main Arm	Experimental	Device: RF Ablation with QDOT MicroSubjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
Second Arm (variable flow)	Experimental	Device: RF Ablation with QDOT Microsubjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 (17 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RF Ablation with QDOT MicroSubjects will be ablated using QDOT Micro catheter	Device	Main Arm, Second Arm (variable flow)

Primary outcome

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

13 secondary outcomes

Number of Participants With Unanticipated Adverse Device Effects (UADEs)
Time frame: 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
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)
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
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)
Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure
Time frame: End of the Procedure (up to 20 months)
Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection
Time frame: Up to 20 months
Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection
Time frame: Up to 20 months
Percentage of Participants With Pulmonary Veins (PV) Touch-up
Time frame: Up to 20 months
Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins
Time frame: Up to 20 months
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
Time frame: Up to 20 months
Percentage of Participants Who Underwent Repeat Ablation Procedures
Time frame: Up to 20 months
Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure
Time frame: Up to 20 months
Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure
Time frame: Up to 20 months
Percentage of Participants With 12-Month Single Procedure Success
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 16 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Arm: QDOT Micro Catheter	191	162
Variable Flow Arm: QDOT Micro Catheter	92	75

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

Time frame: Up to 90 days (post initial and repeated ablation procedure). Number. Unit: Percentage of Participants

Measure	Main Arm: QDOT Micro Catheter n = 167	Variable Flow Arm: QDOT Micro Catheter n = 85
Value	0	0

Population analysed: The modified Intent-to-treat (mITT) analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.

Primary outcome: 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

Time frame: Up to 7 days (post initial and repeated ablation procedure). Number. Unit: Percentage of Participants

Measure	Main Arm: QDOT Micro Catheter n = 167	Variable Flow Arm: QDOT Micro Catheter n = 85
Value	3.6	2.4

Population analysed: The mITT analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.

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

Time frame: Day 91 to Day 365. Number. Unit: Percentage of Participants

Measure	Main Arm: QDOT Micro Catheter n = 156	Variable Flow Arm: QDOT Micro Catheter n = 77
Value	76.3	67.5

Population analysed: 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.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 20 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Arm: QDOT Micro Catheter	32 of 177 (18.1%)	58 of 177 (32.8%)	1 of 177
Variable Flow Arm: QDOT Micro Catheter	14 of 87 (16.1%)	19 of 87 (21.8%)	1 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36752484Osorio J, Hussein AA, Delaughter MC, Monir G, Natale A, Dukkipati S, Oza S, Daoud E, Di Biase L, Mansour M, Fishel R, Valderrabano M, Ellenbogen K; Q-FFICIENCY Trial Investigators. Very High-Power Short-Duration, Temperature-Controlled Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: The Prospective Multicenter Q-FFICIENCY Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):468-480. doi: 10.1016/j.jacep.2022.10.019. Epub 2023 Jan 18.

Related trials for Paroxysmal Atrial Fibrillation

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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emile Daoud principal investigator

Ohio State University

Jose Osorio principal investigator

Grandview Medical Center

Francis Marchlinksi principal investigator

University of Pennsylvania Health System

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RF Ablation with QDOT Micro in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis (time frame: Up to 90 days (post initial and repeated ablation procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03775512, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.