Investigating esophageal injury during atrial fibrillation ablation
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
This study is testing if a new method of heart surgery for atrial fibrillation causes any damage to the esophagus and how that damage changes over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Quovadis Associazione Academic / other |
| Locations | 1 site (Ancona) |
| Trial ID | NCT05758805 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the occurrence and characteristics of esophageal thermal injury (ETI) in patients undergoing atrial fibrillation (AF) ablation using a high-power, short-duration (HP-SD) approach with a contact force sensing catheter. The study involves mini-invasive esophagoscopy before and after the ablation procedure to assess ETI and its potential progression over time. Clinical evaluations will be conducted at 3, 6, and 12 months post-procedure, alongside continuous monitoring of esophageal temperature and other procedural factors that may influence ETI development.
Who should consider this trial
Good fit: Ideal candidates include individuals with atrial fibrillation who are indicated for radiofrequency ablation and can provide informed consent.
Not a fit: Patients with significant comorbidities, such as severe heart failure or esophageal pathologies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing AF ablation by minimizing the risk of esophageal injuries.
How similar studies have performed: While there have been studies on AF ablation, this specific approach focusing on esophageal thermal injury is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Atrial fibrillation and, according to current guidelines, indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter. 2. Able to sign the consent form. Exclusion Criteria: 1. LVEF \< 45% 2. Presence of thrombus in the left atrium 3. NYHA III/IV Class 4. Atrial diameter \> 50mm 5. Moderate or severe valve dysfunction 6. Implanted ICD/CRT-D 7. Life expectancy \< 1 year 8. Uncontrolled Hyperthyroidism 9. Hypertrophic or dilatative cardiomyopathy 10. Kidney failure (eGFR \< 30) 11. Body Mass Index (BMI)\> or = 35 12. Participation in another clinical trial in the past 3 months 13. Inability to express informed consent for the study 14. Patients with esophageal pathologies and a history of gastritis 15. Pregnancy (ascertained by performing the HCG test), breastfeeding, pregnancy planned during the study, or fertile female subjects who refused to use a highly effective contraceptive measure.
Where this trial is running
Ancona
- SOD di Cardiologia e Aritmologia — Ancona, Italy (Recruiting)
Study contacts
- Principal investigator: Antonio Dello Russo, MD — Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)
- Study coordinator: Antonio Dello Russo, MD
- Email: antonio.dellorusso@ospedaliriuniti.marche.it
- Phone: +39 0715965798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.