Trial Outcomes & Findings for Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB. (NCT NCT04545619)
NCT ID: NCT04545619
Last Updated: 2025-06-29
Results Overview
Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all targeted pulmonary veins (PVs) after administration of adenosine/isoproterenol using the nGEN / QDOT Micro Ablation System. The participants without any QMODE+ applications for PVI were considered as a failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to 104 days
Results posted on
2025-06-29
Participant Flow
Participant milestones
| Measure |
QDOT-nGEN Catheter
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
QDOT nGEN Catheter Inserted
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39
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Overall Study
COMPLETED
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39
|
|
Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
QDOT-nGEN Catheter
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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Overall Study
due to equipment challenges
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1
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Baseline Characteristics
Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.
Baseline characteristics by cohort
| Measure |
QDOT-nGEN Catheter
n=40 Participants
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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Age, Continuous
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61.7 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
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Sex: Female, Male
Male
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25 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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40 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 104 daysPopulation: The effectiveness analysis set included all enrolled participants who met all eligibility criteria and had the investigational device inserted and underwent an ablation procedure with the study catheter used in conjunction with QMODE+ and /or QMODE for pulmonary vein isolation (PVI) (RF energy was delivered).
Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all targeted pulmonary veins (PVs) after administration of adenosine/isoproterenol using the nGEN / QDOT Micro Ablation System. The participants without any QMODE+ applications for PVI were considered as a failure.
Outcome measures
| Measure |
QDOT-nGEN Catheter
n=38 Participants
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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Number of Participants Who Achieved Acute Procedural Success
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37 Participants
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SECONDARY outcome
Timeframe: Up to 104 daysPopulation: The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Number of participants with AEs were reported. An AE was any untoward medical occurrence whether or not related to the study device or ablation procedure.
Outcome measures
| Measure |
QDOT-nGEN Catheter
n=39 Participants
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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Number of Participants With Adverse Events (AEs)
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9 Participants
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Adverse Events
QDOT-nGEN Catheter
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QDOT-nGEN Catheter
n=39 participants at risk
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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General disorders
Pyrexia
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Other adverse events
| Measure |
QDOT-nGEN Catheter
n=39 participants at risk
Participants with atrial fibrillation (AF) underwent the ablation procedure with the QDOT MICRO catheter used in combination with the nGEN generator with QDOT software module during standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
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|---|---|
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Nervous system disorders
Headache
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7.7%
3/39 • Number of events 3 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Nervous system disorders
Presyncope
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Gastrointestinal disorders
Gastrooesophageal reflux disease
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
|
|
Gastrointestinal disorders
Impaired gastric emptying
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
|
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Gastrointestinal disorders
Odynophagia
|
2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Infections and infestations
Cystitis
|
2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Infections and infestations
Urinary tract infection
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
|
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Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
|
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Cardiac disorders
Pericardial effusion
|
2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
|
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Endocrine disorders
Hypothyroidism
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Injury, poisoning and procedural complications
Procedural pain
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Renal and urinary disorders
Dysuria
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Vascular disorders
Haematoma
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2.6%
1/39 • Number of events 1 • Up to 104 days
The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
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Additional Information
Associate Director Clinical Research
Biosense Webster, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER