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The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Use of CartoFinder™ device with CARTO® 3 System V5 Navigation to treat complex arrhythmias |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CartoFinder™ Device with CARTO® 3 System V5 Navigation | Device | Ablation treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify rate of slowing for the overall mean atrial fibrillation rate | Identify rate of slowing for the overall mean atrial fibrillation rate that can be achieved by using CARTOFINDER™ 4D LAT Algorithm | Day 0 (procedure date) |
| Evaluate Freedom from procedure-related primary adverse events | Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate procedural results | Proportion of subjects with focal impulses / Repetitive Activation Pattern (RAP)s and number of areas and locations of focal impulses / RAPs | Day 0 (procedure date) |
| Evaluate procedural results |
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Inclusion Criteria:
Age ≥ 18 years.
Signed the Patient Informed Consent Form (ICF)
Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of
Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI).
In AF at the time of the Pre-CartoFinder Map (spontaneous or induced)
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis (AZ) Sint Jan Brugge | Ruddershove | Brugge | 10 - 8000 | Belgium | ||
| Universitair Ziekenhuis A ntwerpen (UZA) |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Proportion of subjects with Normal Sinus Rhythm (NSR) after CF guided ablation
| Day 0 (procedure date) |
| Evaluate procedural results | Proportion of subjects with AF organization after CF guided ablation | Day 0 (procedure date) |
| Evaluate procedural results | Proportion of subjects with acute procedural success, i.e. subjects with spontaneous return to NSR or AF organization after CF guided ablation | Day 0 (procedure date) |
| Evaluate freedom from documented recurrence of atrial fibrillation | Evaluate freedom from documented recurrence of atrial fibrillation at 6 and 12 months post-procedure | 6 and 12 months |
| Wilrijkstraat |
| Edegem |
| 10 - 2650 |
| Belgium |
| Onze-Lieve-Vrouwziekenhuis (OLV) Hospital | Aalst | Moorselbaan | 164 - 9300 | Belgium |
| České Budějovice Hospital | České Budějovice | Němcové | 585/54 - 370 01 | Czechia |