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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxysmal and Early Persistent AFIB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QDOT MICRO System | Device | QDOT Micro Catheter with nGEN Generator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 104 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 104 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cardiologie de Montréal (Montreal Heart Institute) | Montreal | Quebec | H1T 1C8 | Canada |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | Up to 104 days |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director Clinical Research | Biosense Webster, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2021 | Nov 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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. | The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered. | Posted | Count of Participants | Participants | Up to 104 days |
|
|
|
| 0 |
| 39 |
| 1 |
| 39 |
| 8 |
| 39 |
| Presyncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |