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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are:
This study aims to estimate the proportion of esophageal thermal injury (ETI) as a result of the AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter immediately after and at 3, 6, and 12 months from the procedure, as well as describe their characteristics.
To be more sensitive and specific in detecting the presence of potentially chronic and progressing ETIs in esophageal ulcers and atrium-esophageal fistula, a minimally invasive esophagogastroscope will be used before (1-7 days) and after (1-3 days) the ablation procedure, with an internal comparison of the lesions observed. In addition, various clinical characteristics of the patients and descriptors of the ablation procedure (such as contact force, impedance, RF power, RF time, esophageal temperature, procedure times, etc.) will be collected and related to the presence of ETI.
The principal Medical Devices that will be used:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unique Arm | Experimental | patients with atrial fibrillation and indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter, according to current guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mini-invasive esophagoscopy | Device | mini-invasive esophagoscopy assessment of esophageal thermal injury (ETI) after an AF ablation session in an HP-SD setting, and with a tip CF sensing ablation catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of the acute esophageal thermal injury (ETI) | Evaluate the acute proportion of the esophageal thermal injury (ETI) | 1-3 days after AF ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Factors influencing RF procedure on ETI development | Contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development | 1-3 days after AF ablation procedure |
| Esophageal temperature by an esophageal continuous monitoring device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Dello Russo, MD | Contact | +39 â€0715965798‬ | antonio.dellorusso@ospedaliriuniti.marche.it | |
| Franco Noventa, MD | Contact | +39 049715373 | franco.noventa@quovadis-ass.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Dello Russo, MD | Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOD di Cardiologia e Aritmologia | Recruiting | Ancona | 60126 | Italy |
no IPD share planned
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Pilot, about the safety, prospective, monocentric
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| HP-SD AF ablation by a CF sensing catheter | Device | AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter |
|
Celsius degree. |
| during AF ablation procedure |
| ETI monitoring | Chronic (every 3 months until healing) evaluation of discovered ETI. | 12 months after AF ablation procedure |
| AF ablation procedure times | minutes | 1 day |
| AF recurrences | AF recurrences until 12 months after the ablation procedure | 12 months after AF ablation procedure |
| Serious and no serious adverse events | Serious and no serious adverse events after the ablation procedure | 12 months after AF ablation procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D004939 | Esophageal Perforation |
| D004937 | Esophageal Fistula |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014947 | Wounds and Injuries |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
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