Actively Recruiting
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
Led by Quovadis Associazione · Updated on 2024-05-09
51
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
Q
Quovadis Associazione
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
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: * Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen. * Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development. * Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.
CONDITIONS
Official Title
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with atrial fibrillation and eligible for radiofrequency ablation guided by electro-anatomical mapping with a high-density mapping catheter and contact force ablation catheter
- Able to provide informed consent for the study
You will not qualify if you...
- Left ventricular ejection fraction below 45%
- Presence of thrombus in the left atrium
- New York Heart Association (NYHA) Class III or IV heart failure
- Atrial diameter greater than 50 mm
- Moderate or severe valve dysfunction
- Implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
- Life expectancy less than 1 year
- Uncontrolled hyperthyroidism
- Hypertrophic or dilated cardiomyopathy
- Kidney failure with estimated glomerular filtration rate (eGFR) less than 30
- Body mass index (BMI) of 35 or higher
- Participation in another clinical trial within the past 3 months
- Unable to provide informed consent
- Esophageal pathologies or history of gastritis
- Pregnancy, breastfeeding, planning pregnancy during the study, or fertile female subjects refusing effective contraception
AI-Screening
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Trial Site Locations
Total: 1 location
1
SOD di Cardiologia e Aritmologia
Ancona, Italy, 60126
Actively Recruiting
Research Team
A
Antonio Dello Russo, MD
CONTACT
F
Franco Noventa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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