Ultra-High Power Ablation,Safety of Atrial Fibrillation AblationUHP-POP-ESONCT06699368
Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters
A study testing The ultra-high-power ablation group and The high-power ablation group in people with Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation, run by The Third People's Hospital of Chengdu.
Trial summary
This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation
- What is being tested?
- The ultra-high-power ablation group and The high-power ablation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years old.
- Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.
- Non-valvular atrial fibrillation.
- Able to understand the purpose of the study, voluntarily participate in this research, and the patient or their legal representative signs the informed consent form, willing to complete follow-ups as required by the protocol.
Who cannot join
- Atrial fibrillation secondary to thyroid disease or other reversible factors;
- Imaging studies indicating intracardiac thrombus;
- Moderate to severe mitral stenosis or regurgitation;
- Left ventricular ejection fraction <40%, or New York Heart Association (NYHA) functional class III or IV;
- Unstable angina;
- Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;
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- Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;
- Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;
- Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;
- Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;
- Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;
- Conditions affecting vascular access;
- Patients who are concurrently participating in other drug or device clinical trials;
- Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.
Read the detailed description
This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.
- Being tested
- The ultra-high-power ablation group, The high-power ablation group
- Keywords
- Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ultra-high-power ablation groupProcedure or surgery
The ultra-high-power ablation group will use the QDOT ablation catheter with a power of 90W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g. The cold saline flow rate during ablation is 8ml/min, and the ablation device will adjust power and saline flow rate based on the electrode temperature at the tip of the QDOT ablation catheter. The target temperature is 60°C, and the cut-off temperature is 65°C, with an ablation endpoint of 4 seconds.
The high-power ablation groupProcedure or surgery
The high-power ablation group will use the STSF ablation catheter with a power of 50W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g, and a cold saline flow rate of 15ml/min during ablation. The ablation endpoint for the posterior wall of the left atrium is an Ablation Index (AI) value of 360-410, for the anterior wall 450-480, and for the bottom and top of the left atrium 420-450.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-High-Power Ablation Group | Experimental | The ultra-high-power ablation group will use the QDOT ablation catheter with a power of 90W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g. The cold saline flow rate during ablation is 8ml/min, and the ablation device will adjust power and saline flow rate based on the electrode temperature at the tip of the QDOT ablation catheter. The target temperature is 60°C, and the cut-off temperature is 65°C, with an ablation endpoint of 4 seconds. Receives: Procedure: The ultra-high-power ablation group |
| High-Power Ablation Group | Active comparator | The high-power ablation group will use the STSF ablation catheter with a power of 50W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g, and a cold saline flow rate of 15ml/min during ablation. The ablation endpoint for the posterior wall of the left atrium is an Ablation Index (AI) value of 360-410, for the anterior wall 450-480, and for the bottom and top of the left atrium 420-450. Receives: Procedure: The high-power ablation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C
The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C
Measured: Intraoperative Immediate
Secondary outcomes (1)
The number of times Intraoperative steam POP occurrence
The number of times Intraoperative steam POP occurrence
Measured: Intraoperative Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start28 Nov 2024 (estimated)
- Primary completion5 May 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-High Power Ablation,Safety of Atrial Fibrillation AblationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanxiong Liu, The Third People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699368
- Sponsor's protocol ID
- CDSY-UHP-POP-ESO
- Acronym
- UHP-POP-ESO
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters
- ClinicalTrials.gov ID
- NCT06699368
- Acronym / sponsor ID
- UHP-POP-ESO / CDSY-UHP-POP-ESO
- Keywords
- Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Study start
- 28 Nov 2024 (estimated)
- Primary completion
- 5 May 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 21 Nov 2024 (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 study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.
Detailed description
This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-High-Power Ablation Group | Experimental | Procedure: The ultra-high-power ablation groupThe ultra-high-power ablation group will use the QDOT ablation catheter with a power of 90W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g. The cold saline flow rate during ablation is 8ml/min, and the ablation device will adjust power and saline flow rate based on the electrode temperature at the tip of the QDOT ablation catheter. The target temperature is 60°C, and the cut-off temperature is 65°C, with an ablation endpoint of 4 seconds. |
| High-Power Ablation Group | Active comparator | Procedure: The high-power ablation groupThe high-power ablation group will use the STSF ablation catheter with a power of 50W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g, and a cold saline flow rate of 15ml/min during ablation. The ablation endpoint for the posterior wall of the left atrium is an Ablation Index (AI) value of 360-410, for the anterior wall 450-480, and for the bottom and top of the left atrium 420-450. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 80 years old.
- Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.
- Non-valvular atrial fibrillation.
- Able to understand the purpose of the study, voluntarily participate in this research, and the patient or their legal representative signs the informed consent form, willing to complete follow-ups as required by the protocol.
Key exclusion criteria (14 listed)
- Atrial fibrillation secondary to thyroid disease or other reversible factors;
- Imaging studies indicating intracardiac thrombus;
- Moderate to severe mitral stenosis or regurgitation;
- Left ventricular ejection fraction <40%, or New York Heart Association (NYHA) functional class III or IV;
- Unstable angina;
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 |
|---|---|---|
| The ultra-high-power ablation groupThe ultra-high-power ablation group will use the QDOT ablation catheter with a power of 90W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g. The cold saline flow rate during ablation is 8ml/min, and the ablation device will adjust power and saline flow rate based on the electrode temperature at the tip of the QDOT ablation catheter. The target temperature is 60°C, and the cut-off temperature is 65°C, with an ablation endpoint of 4 seconds. | Procedure or surgery | Ultra-High-Power Ablation Group |
| The high-power ablation groupThe high-power ablation group will use the STSF ablation catheter with a power of 50W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g, and a cold saline flow rate of 15ml/min during ablation. The ablation endpoint for the posterior wall of the left atrium is an Ablation Index (AI) value of 360-410, for the anterior wall 450-480, and for the bottom and top of the left atrium 420-450. | Procedure or surgery | High-Power Ablation Group |
Primary outcome
The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C
Time frame: Intraoperative Immediate
The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C
1 secondary outcome
The number of times Intraoperative steam POP occurrence
Time frame: Intraoperative Immediate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing The ultra-high-power ablation group and The high-power ablation group in people with Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation, run by The Third People's Hospital of Chengdu.
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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof.Liu (8613551044286, lhanx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C (time frame: Intraoperative Immediate). 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 21 Nov 2024.