Atrial Fibrillation (AF)NCT06632925
Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software: a Prospective Study
An observational study of Atrial Fibrillation (AF), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
A single-center clinical trial on the analysis of intracardiac atrial electrogram mapping before and after ablation with the HD Grid Mapping Catheter and Ensite X Software, as a prospective study. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Catheter ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 30 Jun 2027
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Criteria for inclusion (same as current inclusion criteria for catheter ablation of AF): 1. Patents who sign the informed consent forms, and allow to be followed. 2. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication. 3. Patients with age equal or greater than 20 years old regardless of gender. Criteria for exclusion (same as current inclusion criteria for catheter ablation of AF): 1. The presence of a atrial or ventricular thrombus. 2. Patients who are allergic to or unsuitable for use with the contrast media. 3. Pregnant patients or patients who are unavailable to receive X-ray. 4. Patients with renal insufficiency. 5. Patients had autonomic nervous system disorder (e.g. respiratory apnea) 6. Patients with age less than 20 years old or greater than 80 years old regardless of gender.
Who may be able to join
- Patents who sign the informed consent forms, and allow to be followed.
- Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
- Patients with age equal or greater than 20 years old regardless of gender.
Who cannot join
- The presence of a atrial or ventricular thrombus.
- Patients who are allergic to or unsuitable for use with the contrast media.
- Pregnant patients or patients who are unavailable to receive X-ray.
- Patients with renal insufficiency.
- Patients had autonomic nervous system disorder (e.g. respiratory apnea)
- Patients with age less than 20 years old or greater than 80 years old regardless of gender.
Trial locations and contacts
1 site in 1 country.
About this study
A single-center clinical trial on the analysis of intracardiac atrial electrogram mapping before and after ablation with the HD Grid Mapping Catheter and Ensite X Software, as a prospective study.
Read the detailed description
This study was designed to determine the efficacy of substrate ablation using HD Grid Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification in AF patients who required substrate modification. This study is a prospective, single-center in which patients with AF who will receive catheter ablation.
The priority of substrate modification would be determined by the mapping with the HD Grid mapping catheter. The end-point of ablation is non-inducible of AF or AFL. The procedure time, fluoroscopic time, procedural termination rate, and recurrence of atrial arrhythmia would be collected. If the flutter or the non-PV triggers were inducible, isthmus ablation and the non-PV trigger ablation will be performed accordingly.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Catheter ablation
- Keywords
- Atrial Fibrillation, Ensite X Software, Atrial arrhythmia, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
The catheter ablation strategy is the same as the current treatment approach in patients with AF, according to the consensus of catheter ablation of AF. All procedures will be performed under local sedation or general anesthesia depending on the operator, and each patient will undergo an electrophysiological study and substrate mapping in the fasting state with adequate pre-ablation anticoagulation and transesophageal echocardiography to rule out LA thrombus. All antiarrhythmic drugs except amiodarone will be discontinued for at least 5 half-lives before the procedure.
Step I: Substrate mapping before ablation, Step II: Pulmonary vein isolation (PVI), Step III: Post-ablation mapping in SR immediately after ablation, Step IV: Inducibility after ablation, Step V: Remmaping 30 minutes after ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-procedure freedom from AF
The study's primary endpoint was single-procedure freedom from AF after a blanking period based on a single procedure.
After discharge, the patients were followed up (two weeks after the catheter ablation, then every 3 months) at our cardiology clinic or with the referring physician. During each follow-up, 24-hour Holter monitoring, or cardiac event recording was performed for a week. A 7-day holter will be performed in the 6th and 12th months. Recurrence was defined as any atrial arrhythmia recurrence, including AF and atrial tachycardia, and was defined as an episode lasting >1 minute and confirmed by ECGs months after the ablation.
Measured: From the catheter ablation date to 12 months
Secondary outcomes (3)
Non-inducibility of AF or AFL
Measured: During catheter ablation procedure
Any recurrence of all atrial arrhythmias after the first procedure
A 7-day holter will be performed in the 6th and 12th months.
Measured: In the 6th and 12th months after catheter ablation.
Safety
This outcome measure will assess the procedural time, radiation exposure time, and the incidence of major complications, including cardiac tamponade, peripheral aneurysm, cerebral infarction, and shock
Measured: From the catheter ablation date to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chin-Yu Lin, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632925
- Sponsor's protocol ID
- 2024-03-001A
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software: a Prospective Study
- ClinicalTrials.gov ID
- NCT06632925
- Acronym / sponsor ID
- 2024-03-001A
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Ensite X Software, Atrial arrhythmia, Catheter ablation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Oct 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.
A single-center clinical trial on the analysis of intracardiac atrial electrogram mapping before and after ablation with the HD Grid Mapping Catheter and Ensite X Software, as a prospective study.
Detailed description
This study was designed to determine the efficacy of substrate ablation using HD Grid Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification in AF patients who required substrate modification. This study is a prospective, single-center in which patients with AF who will receive catheter ablation.
The priority of substrate modification would be determined by the mapping with the HD Grid mapping catheter. The end-point of ablation is non-inducible of AF or AFL. The procedure time, fluoroscopic time, procedural termination rate, and recurrence of atrial arrhythmia would be collected. If the flutter or the non-PV triggers were inducible, isthmus ablation and the non-PV trigger ablation will be performed accordingly.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Criteria for inclusion (same as current inclusion criteria for catheter ablation of AF): 1. Patents who sign the informed consent forms, and allow to be followed. 2. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication. 3. Patients with age equal or greater than 20 years old regardless of gender. Criteria for exclusion (same as current inclusion criteria for catheter ablation of AF): 1. The presence of a atrial or ventricular thrombus. 2. Patients who are allergic to or unsuitable for use with the contrast media. 3. Pregnant patients or patients who are unavailable to receive X-ray. 4. Patients with renal insufficiency. 5. Patients had autonomic nervous system disorder (e.g. respiratory apnea) 6. Patients with age less than 20 years old or greater than 80 years old regardless of gender.
Key inclusion criteria (3 listed)
- Patents who sign the informed consent forms, and allow to be followed.
- Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
- Patients with age equal or greater than 20 years old regardless of gender.
Key exclusion criteria (6 listed)
- The presence of a atrial or ventricular thrombus.
- Patients who are allergic to or unsuitable for use with the contrast media.
- Pregnant patients or patients who are unavailable to receive X-ray.
- Patients with renal insufficiency.
- Patients had autonomic nervous system disorder (e.g. respiratory apnea)
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 |
|---|---|---|
| Catheter ablationThe catheter ablation strategy is the same as the current treatment approach in patients with AF, according to the consensus of catheter ablation of AF. All procedures will be performed under local sedation or general anesthesia depending on the operator, and each patient will undergo an electrophysiological study and substrate mapping in the fasting state with adequate pre-ablation anticoagulation and transesophageal echocardiography to rule out LA thrombus. All antiarrhythmic drugs except amiodarone will be discontinued for at least 5 half-lives before the procedure. Step I: Substrate mapping before ablation, Step II: Pulmonary vein isolation (PVI), Step III: Post-ablation mapping in SR immediately after ablation, Step IV: Inducibility after ablation, Step V: Remmaping 30 minutes after ablation | Procedure or surgery | – |
Primary outcome
Single-procedure freedom from AF
Time frame: From the catheter ablation date to 12 months
The study's primary endpoint was single-procedure freedom from AF after a blanking period based on a single procedure. After discharge, the patients were followed up (two weeks after the catheter ablation, then every 3 months) at our cardiology clinic or with the referring physician. During each follow-up, 24-hour Holter monitoring, or cardiac event recording was performed for a week. A 7-day holter will be performed in the 6th and 12th months. Recurrence was defined as any atrial arrhythmia recurrence, including AF and atrial tachycardia, and was defined as an episode lasting >1 minute and confirmed by ECGs months after the ablation.
3 secondary outcomes
Non-inducibility of AF or AFL
Time frame: During catheter ablation procedure
Any recurrence of all atrial arrhythmias after the first procedure
Time frame: In the 6th and 12th months after catheter ablation.
Safety
Time frame: From the catheter ablation date to 12 months follow-up
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 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Oct 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 Taiwan. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-procedure freedom from AF (time frame: From the catheter ablation date to 12 months). 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 17 Oct 2024.