Arrhythmias
Conditions
Brief summary
The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.
Interventions
PROCEDUREAblation procedure
The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intra-cardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.
DEVICEPicasso NAV Catheter
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this clinical investigation. 1. Age \> 18 years or older. 2. Patients who have signed the Patient Informed Consent Form (ICF) 3. Patients who are scheduled to undergo a clinically-indicated catheter ablation procedure for the management of a complex arrhythmia. (Patients having undergone a previous ablation procedure may be included.) 4. Subjects who have failed at least one antiarrhythmic drug (AAD) (including AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic complex arrhythmia, or intolerable to the AAD 5. Complex arrhythmias (including atrial fibrillation, atypical flutter, ventricular tachycardia) defined as patients who have been diagnosed with a complex arrhythmia anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above. 6. At least one episode of the complex arrhythmia must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment. 7. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-procedural investigational device success | Intra-procedure | Intra-procedural investigational device success * Ability to deploy the Picasso NAV Catheter within the atria and/or ventricles * The collection of intra-cardiac signals in the atria and/or ventricles Measured by number and percentage of physicians able to deploy and collect intra-cardiac signals as outlined in the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the ideal workflow | Intra-procedure | Characterize the ideal workflow (defined as catheter preparation, connectivity, and configuration) and the use of the Picasso NAV Catheter's ability to map areas of interest Measured by survey questions |
| Visualize the device | Up to 3 months | Ability to visualize the device Measured by survey questions |
| Overall safety | Up to 7 days | Overall safety * Primary Adverse Events * Procedural complications Measured by number and percentage of patients experiencing those adverse events |
Outcome results
None listed