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Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions
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The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.
This study is a prospective, multi-center, randomized (2:1), controlled, two-arm, unblinded, clinical study, which will evaluate the efficacy, safety, and efficiency of CARTO® 3 System-guided RF ablation (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using the PVAC®). Patients with symptomatic PAF who meet the inclusion criteria will be considered for study participation and may be enrolled if no exclusion criteria apply.
Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THERMOCOOL® group | Other | Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter. |
|
| PVAC® group | Active Comparator | Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation procedure | Device | Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from documented AF/AT recurrences without new AADs | Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation. | 1 year follow-up post-ablation |
| Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI) | at 6 months post-ablation | |
| Total procedure time | at the time of the initial ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success | Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure | at the time of the initial ablation procedure |
| Repeat ablation procedures for AF/AT recurrences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mattias Duytschaever, MD | A.Z. St Jan AV | Principal Investigator |
| Yves De Greef, MD | A.Z. Middelheim | Principal Investigator |
| Stuart Harris, MD | Essex Cardiothoracic Centre | Principal Investigator |
| Peter Steen Hansen, MD | Heart Center Varde | Principal Investigator |
| Pepijn Van Der Voort, MD | Catharina Ziekenhuis | Principal Investigator |
| Thomas Deneke, MD | Krankenhaus Porz Cologne | Principal Investigator |
| Atul Verma, MD | Southlake Health | Principal Investigator |
| Arif Elvan, MD | Isala | Principal Investigator |
| Yaariv Khaykin, MD | Southlake Health | Principal Investigator |
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|
|
| Radiofrequency Ablation procedure | Device | Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins. |
|
|
Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT
| through 3-12 month follow-up period post-ablation |
| Freedom from documented AF/AT recurrences without AAD(s) | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation |
| Freedom from documented AF/AT recurrences with AAD(s) | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation |
| Freedom from documented AF/AT recurrences after more than one ablation procedure | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation |
| Freedom from documented AF recurrences without AADs | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation |
| Freedom from documented AF recurrences with AAD(s) | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation |
| Freedom from documented symptomatic AF/AT recurrences without new AAD(s) | Measured by % achieving freedom from documented symptomatic AF/AT recurrences | through 3-12 month follow-up period post-ablation |
| Freedom from documented symptomatic AF/AT recurrences with AAD(s) | through 3-12 month follow-up period post-ablation |
| Incidence of any procedure-related and/or device-related adverse events occurring during the study | through 1 year follow-up |
| Incidence of any catheter-related adverse events | during 7 days follow-up post-ablation |
| Total Fluoroscopy exposure time | Measured by fluoroscopy and cine-fluoroscopy time throughout procedure | at the time of the ablation procedure |
| Total Fluoroscopy Dose-Area Product/Source Intensifier Distance | at the time of the ablation procedure |
| Incidence of any phrenic nerve paralysis | through 1 year follow-up post-ablation |
| Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) | through 1 year follow-up post-ablation |
| Number of mapping and ablation catheters used per subject | through 1 year follow-up post-ablation |
| Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment | Baseline, 3, 6 and 12 months |
| Total procedure hospital visit and ablation procedure costs | during hospitalization stay for study treatment |
| Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits) | through 1 year follow-up post-ablation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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