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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001890-34 | EudraCT Number |
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Clinical study intended to evaluate the feasibility of a new irrigated RF ablation catheter that allows the physiologist to perform a regular RF ablation procedure while it is being monitored through an imaging technique known as Optical Coherence Reflectometry (OCR). This technique is based upon the use of infrared light; it is innocuous for the human body and allows for the detection of the contact between the catheter tip with the tissue besides the lesion formation during the Radiofrequency (RF) application as the OCR technique is able to distinguish between ablated tissue and healthy tissue. Both features are able to provide a better control of the ablation procedure, which may become in a better clinical result in cardiac ablation procedures, especially in Atrial Fibrillation cases.
This feasibility study intended for the evaluation of the technique in humans prior to a Safety and efficacy study based on the non-inferiority of AblaView® Ablation Catheter against a control device. Thus, no randomization has been decided and no blinding has been considered necessary.
The primary clinical endpoints of this investigation are as follows:
The Primary Endpoint 2 will be measured according to the clinical practice guidance for the evaluation of: ictus, cardiac tamponades, major hemorrhage, esophageal lesion and death, and will be recorded right after the procedure and in the patient record for the 30 days follow up visit.
The Secondary Endpoint 1 will be measured according to the Principal investigator's criteria and the assessment of the Medlumics technician for the evaluation of detachable parts, irrigation leaks, malfunction of the handling/steering, break of electrical parts and "pop" occurrence), and will be recorded right after the procedure and in the patient record for the 30 days follow up visit.
Subjects will only be replaced if the recruitment period is not ended and the eligible number of patients is under 15, they will not be replaced if they get excluded after the beginning of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation patients | Experimental | Single-Arm study, all patients included will undergo RF ablation using AblaView® Ablation Catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AblaView® Ablation Catheter | Device | The AblaView® Ablation Catheter is a regular RF ablation catheter with the same physical characteristics and the same biocompatible materials, with an 8 French (2.66 mm) sheath and 180º deflection angle. The tip of the catheter has 15 holes distributed around it where the irrigation will be delivered into the patient's blood. The front irrigation hole will deliver at the same time the infrared light for the OCR system. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the technique in humans | Validate that the technique is able to provide real time image of the change in the optical properties of the heart tissue during the ablation procedure. This change will be analyzed intraoperative because untreated myocardial tissue has a high level of cellular organization, which exhibits a significant phase retardation between orthogonal polarization states, leading to reflect polarized light. But birefringence property disappears by applying RF power during time on the same location, because the fibers are denaturalized. This optical change can be measured to provide a reliable marker for cellular and subcellular organization to estimate lesion formation in real time | at completion of the procedure with AblaView® Ablation Catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the technique on occurence of adverse effects (Safety and Tolerability) | major complications incidence (equal to or below regular procedure incidence of serious adverse events of 5%) within the 30 days after the procedure (ictus, cardiac tamponade, major hemorrhage, esophageal lesion, death) | 30 days after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stepan Kralovec | Authorised representative in the Czech Republic | Study Director |
| Petr Neuzil, MD | Na Homolce Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | 150 30 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26417499 | Background | Herranz D, Lloret J, Jimenez-Valero S, Rubio-Guivernau JL, Margallo-Balbas E. Novel catheter enabling simultaneous radiofrequency ablation and optical coherence reflectometry. Biomed Opt Express. 2015 Aug 7;6(9):3268-75. doi: 10.1364/BOE.6.003268. eCollection 2015 Sep 1. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Validation of the usability and design of the medical device |
complications incidence within the 30 days after the procedure (Detachable parts, irrigation leak, malfunction of the handling/steering, break of electrical parts and "pop" occurrence) |
| 30 days after the procedure of ablation with AblaView® Ablation Catheter is completed |
| D013568 |
| Pathological Conditions, Signs and Symptoms |