Atrial Fibrillation
Conditions
Brief summary
This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.
Interventions
DEVICEQDOT MICRO System
QDOT Micro Catheter with nGEN Generator
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation. 2. Age 18 or older. 3. Signed the Patient Informed Consent Form (ICF).
Exclusion criteria
1. If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks. 2. Presence of a myxoma or an intracardiac thrombus. 3. Presence of prosthetic valves. 4. Presence of active systemic infection 5. Patient with an interatrial baffle or patch 6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), 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 |
|---|---|---|
| Number of Participants Who Achieved Acute Procedural Success | Up to 104 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 104 days | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | due to equipment challenges | 1 |
Baseline characteristics
| Characteristic | QDOT-nGEN Catheter |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 8 / 39 |
| serious Total, serious adverse events | 1 / 39 |
Outcome results
Primary
Number of Participants Who Achieved Acute Procedural Success
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.
Time frame: Up to 104 days
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QDOT-nGEN Catheter | Number of Participants Who Achieved Acute Procedural Success | 37 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
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.
Time frame: Up to 104 days
Population: The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QDOT-nGEN Catheter | Number of Participants With Adverse Events (AEs) | 9 Participants |