Atrial FibrillationESO-SAFE-HP-RFNCT05758805
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
A study testing mini-invasive esophagoscopy and HP-SD AF ablation by a CF sensing catheter in people with Atrial Fibrillation and Esophageal Perforation, run by Quovadis Associazione at 1 site in Italy.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Esophageal Perforation, Esophageal Fistula
- What is being tested?
- mini-invasive esophagoscopy and HP-SD AF ablation by a CF sensing catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Able to sign the consent form.
Who cannot join
- LVEF < 45%
- Presence of thrombus in the left atrium
- NYHA III/IV Class
- Atrial diameter > 50mm
- Moderate or severe valve dysfunction
- Implanted ICD/CRT-D
Show all 15Show fewer
- Life expectancy < 1 year
- Uncontrolled Hyperthyroidism
- Hypertrophic or dilatative cardiomyopathy
- Kidney failure (eGFR < 30)
- Body Mass Index (BMI)> or = 35
- Participation in another clinical trial in the past 3 months
- Inability to express informed consent for the study
- Patients with esophageal pathologies and a history of gastritis
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
SOD di Cardiologia e Aritmologia
Ancona, 60126
Antonio Dello Russo, MD, 071 5965799, antonio.dellorusso@ospedaliriuniti.marche.it
About this study
Official title: Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
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.
Read the detailed description
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:
- Cardiac Mapping system Ensite X (Abbott Medical),
- Tip CF sensing catheter TactiFlex (Abbott Medical),
- High mapping density catheter (HD GRID/Advisor FL, Abbott Medical),
- Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB),
- Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).
- Being tested
- mini-invasive esophagoscopy, HP-SD AF ablation by a CF sensing catheter
- Keywords
- esophageal thermal injury (ETI), AF ablation, high-power, short-duration (HP-SD), mini-invasive esophagoscopy
- Medical subject headings
- Atrial Fibrillation, Esophageal Perforation, Esophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-invasive esophagoscopyDevice
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
HP-SD AF ablation by a CF sensing catheterDevice
AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: mini-invasive esophagoscopy; Device: HP-SD AF ablation by a CF sensing catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the acute esophageal thermal injury (ETI)
Evaluate the acute proportion of the esophageal thermal injury (ETI)
Measured: 1-3 days after AF ablation procedure
Secondary outcomes (6)
Factors influencing RF procedure on ETI development
Contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development
Measured: 1-3 days after AF ablation procedure
Esophageal temperature by an esophageal continuous monitoring device
Celsius degree.
Measured: during AF ablation procedure
ETI monitoring
Chronic (every 3 months until healing) evaluation of discovered ETI.
Measured: 12 months after AF ablation procedure
AF ablation procedure times
minutes
Measured: 1 day
AF recurrences
AF recurrences until 12 months after the ablation procedure
Measured: 12 months after AF ablation procedure
Serious and no serious adverse events
Serious and no serious adverse events after the ablation procedure
Measured: 12 months after AF ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start8 Jan 2024
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, about the safety, prospective, monocentric
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quovadis Associazione
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Antonio Dello Russo, MD, Principal investigator, Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758805
- Sponsor's protocol ID
- ESO-SAFE-HP-RF Study
- Acronym
- ESO-SAFE-HP-RF
- Status last verified
- May 2024
- First submitted
- 21 Feb 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD share planned
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
- ClinicalTrials.gov ID
- NCT05758805
- Acronym / sponsor ID
- ESO-SAFE-HP-RF / ESO-SAFE-HP-RF Study
- Keywords
- esophageal thermal injury (ETI), AF ablation, high-power, short-duration (HP-SD), mini-invasive esophagoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Quovadis AssociazioneUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Cardiac Mapping system Ensite X (Abbott Medical),
- Tip CF sensing catheter TactiFlex (Abbott Medical),
- High mapping density catheter (HD GRID/Advisor FL, Abbott Medical),
- Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB),
- Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, about the safety, prospective, monocentric
| Arm | Type | Receives |
|---|---|---|
| Unique Arm | Experimental | Device: mini-invasive esophagoscopy, Device: HP-SD AF ablation by a CF sensing catheterpatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- Able to sign the consent form.
Key exclusion criteria (15 listed)
- LVEF < 45%
- Presence of thrombus in the left atrium
- NYHA III/IV Class
- Atrial diameter > 50mm
- Moderate or severe valve dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mini-invasive esophagoscopymini-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 | Device | Unique Arm |
| HP-SD AF ablation by a CF sensing catheterAF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter | Device | Unique Arm |
Primary outcome
Proportion of the acute esophageal thermal injury (ETI)
Time frame: 1-3 days after AF ablation procedure
Evaluate the acute proportion of the esophageal thermal injury (ETI)
6 secondary outcomes
Factors influencing RF procedure on ETI development
Time frame: 1-3 days after AF ablation procedure
Esophageal temperature by an esophageal continuous monitoring device
Time frame: during AF ablation procedure
ETI monitoring
Time frame: 12 months after AF ablation procedure
AF ablation procedure times
Time frame: 1 day
AF recurrences
Time frame: 12 months after AF ablation procedure
Serious and no serious adverse events
Time frame: 12 months after AF ablation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. no IPD share planned
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Paroxysmal AF
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Dello Russo, MD principal investigator
Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini-invasive esophagoscopy and HP-SD AF ablation by a CF sensing catheter in people with Atrial Fibrillation and Esophageal Perforation, run by Quovadis Associazione at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Dello Russo, MD (+39 0715965798, antonio.dellorusso@ospedaliriuniti.marche.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the acute esophageal thermal injury (ETI) (time frame: 1-3 days after AF ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.