Atrial Fibrillation, PersistentNCT05333952
Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
A study testing Pulmonary vein isolation and Substrate ablation(PRISM based) in people with Atrial Fibrillation, Persistent, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Pulmonary vein isolation and Substrate ablation(PRISM based)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2019to 31 Dec 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
- 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) or previous catheter ablation in the LA or MAZE procedure.
- Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
- Patients with age less than 20 years old or greater than 90 years old regardless of gender.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei General Veterans Hospital
Taipei, 112
Yenn-Jiang Lin, MD, PhD
About this study
Official title: A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.
Read the detailed description
In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.
The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Pulmonary vein isolation, Substrate ablation(PRISM based)
- Keywords
- Catheter ablation, Mapping technique, Substrate mapping, Non-linear electrogram morphology analysis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
The 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module. Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.
Substrate ablation(PRISM based)Procedure or surgery
Substrate modification will be guided by waveform periodicity analysis. The User Defined Map of waveform periodicity analysis will be also created by CARTO 3 system (version 6) with and VISITAG ODP module. Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). Substrate modification based on waveform periodicity analysis will be performed by using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation + Waveform Periodicity Group | Experimental | Pulmonary vein isolation + Substrate ablation Receives: Procedure: Pulmonary vein isolation; Procedure: Substrate ablation(PRISM based) |
| Pulmonary vein isolation group | Other | Pulmonary vein isolation (Conventional treatment) Receives: Procedure: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation
A 24-hour Holter monitoring and/or ECG (7 days recordings) will be performed at 3, 6, 9, and 12 months post ablation and/or when the patients experience symptoms suggestive of a tachycardia after the ablation.
Measurements: documentation of AF signal duration more than 30 seconds.
Measured: Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation
Secondary outcomes (3)
LAD
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF.
LAD [left atrial diameter]
Measured: after catheter ablation of atrial fibrillation 3, 6, 12 month
LVEF
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF.
LVEF [left ventricular ejection fraction]
Measured: after catheter ablation of atrial fibrillation 3, 6, 12 month
e/e'
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF.
e/e'[the ratio of early diastolic mitral inflow velocity to early diastolic mitral annulus velocity]
Measured: after catheter ablation of atrial fibrillation 3, 6, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start19 Feb 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yenn-Jiang Lin, MD, PhD, Principal investigator, Director of Cardiology Division of Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333952
- Sponsor's protocol ID
- 2018-07-008C
- Status last verified
- Jun 2022
- First submitted
- 1 Apr 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient's data was available to the host of IRB.
Publications
Lin CY, Lin YJ, Lo MT, Chiang CH, Chen YY, Kuo L, Chang SL, Lo LW, Hu YF, Chao TF, Chung FP, Liao JN, Chang TY, Lin C, Tuan TC, Wu CI, Liu CM, Liu SH, Cheng WH, Lugtu IC, Jain A, Ton AN, Hermanto DY, Chen SA. Efficacy of Patient-Specific Strategy: Catheter Ablation Strategy of Persistent Atrial Fibrillation Based on Morphological Repetitiveness by Periodicity and Similarity. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009719. doi: 10.1161/CIRCEP.121.009719. Epub 2021 May 17. No abstract available.
PubMed 33998256Hsieh YC, Lin YJ, Lo MT, Chen YY, Lin CY, Lin C, Chung FP, Lo LW, Chang SL, Chao TF, Hu YF, Tuan TC, Liao JN, Wu CI, Liu CM, Vicera JB, Chen CC, Chin CG, Lugtu IC, Chen SA. Optimal substrate modification strategies using catheter ablation in patients with persistent atrial fibrillation: 3-year follow-up outcomes. J Cardiovasc Electrophysiol. 2021 Jun;32(6):1561-1571. doi: 10.1111/jce.15033. Epub 2021 May 5.
PubMed 33825268Lin CY, Lin YJ, Narayan SM, Baykaner T, Lo MT, Chung FP, Chen YY, Chang SL, Lo LW, Hu YF, Liao JN, Tuan TC, Chao TF, Te ALD, Kuo L, Vicera JJB, Chang TY, Salim S, Chien KL, Chen SA. Comparison of phase mapping and electrogram-based driver mapping for catheter ablation in atrial fibrillation. Pacing Clin Electrophysiol. 2019 Feb;42(2):216-223. doi: 10.1111/pace.13573. Epub 2018 Dec 27.
PubMed 30536679Lin CY, Lin YJ, Higa S, Tsai WC, Lo MT, Chiang CH, Chang SL, Lo LW, Hu YF, Chao TF, Chung FP, Liao JN, Chang TY, Lin C, Tuan TC, Kuo L, Wu CI, Liu CM, Liu SH, Kuo MJ, Liao YC, Chuang CM, Chen YY, Hsieh YC, Chen SA. Catheter Ablation With Morphologic Repetitiveness Mapping for Persistent Atrial Fibrillation. JAMA Netw Open. 2023 Nov 1;6(11):e2344535. doi: 10.1001/jamanetworkopen.2023.44535.
PubMed 37991761
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05333952
- Acronym / sponsor ID
- 2018-07-008C
- Conditions
- Atrial Fibrillation, Persistent
- Keywords
- Catheter ablation, Mapping technique, Substrate mapping, Non-linear electrogram morphology analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.
Detailed description
In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.
The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation + Waveform Periodicity Group | Experimental | Procedure: Pulmonary vein isolation, Procedure: Substrate ablation(PRISM based)Pulmonary vein isolation + Substrate ablation |
| Pulmonary vein isolation group | Other | Procedure: Pulmonary vein isolationPulmonary vein isolation (Conventional treatment) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
- Patients with age equal or greater than 20 years old regardless of gender.
Key exclusion criteria (7 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) or previous catheter ablation in the LA or MAZE procedure.
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 |
|---|---|---|
| Pulmonary vein isolationThe 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module. Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode. | Procedure or surgery | Pulmonary vein isolation + Waveform Periodicity Group, Pulmonary vein isolation group |
| Substrate ablation(PRISM based)Substrate modification will be guided by waveform periodicity analysis. The User Defined Map of waveform periodicity analysis will be also created by CARTO 3 system (version 6) with and VISITAG ODP module. Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). Substrate modification based on waveform periodicity analysis will be performed by using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode. | Procedure or surgery | Pulmonary vein isolation + Waveform Periodicity Group |
Primary outcome
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation
Time frame: Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation
A 24-hour Holter monitoring and/or ECG (7 days recordings) will be performed at 3, 6, 9, and 12 months post ablation and/or when the patients experience symptoms suggestive of a tachycardia after the ablation. Measurements: documentation of AF signal duration more than 30 seconds.
3 secondary outcomes
LAD
Time frame: after catheter ablation of atrial fibrillation 3, 6, 12 month
LVEF
Time frame: after catheter ablation of atrial fibrillation 3, 6, 12 month
e/e'
Time frame: after catheter ablation of atrial fibrillation 3, 6, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Results publication: PubMed 33998256Lin CY, Lin YJ, Lo MT, Chiang CH, Chen YY, Kuo L, Chang SL, Lo LW, Hu YF, Chao TF, Chung FP, Liao JN, Chang TY, Lin C, Tuan TC, Wu CI, Liu CM, Liu SH, Cheng WH, Lugtu IC, Jain A, Ton AN, Hermanto DY, Chen SA. Efficacy of Patient-Specific Strategy: Catheter Ablation Strategy of Persistent Atrial Fibrillation Based on Morphological Repetitiveness by Periodicity and Similarity. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009719. doi: 10.1161/CIRCEP.121.009719. Epub 2021 May 17. No abstract available.
- Results publication: PubMed 33825268Hsieh YC, Lin YJ, Lo MT, Chen YY, Lin CY, Lin C, Chung FP, Lo LW, Chang SL, Chao TF, Hu YF, Tuan TC, Liao JN, Wu CI, Liu CM, Vicera JB, Chen CC, Chin CG, Lugtu IC, Chen SA. Optimal substrate modification strategies using catheter ablation in patients with persistent atrial fibrillation: 3-year follow-up outcomes. J Cardiovasc Electrophysiol. 2021 Jun;32(6):1561-1571. doi: 10.1111/jce.15033. Epub 2021 May 5.
- Results publication: PubMed 30536679Lin CY, Lin YJ, Narayan SM, Baykaner T, Lo MT, Chung FP, Chen YY, Chang SL, Lo LW, Hu YF, Liao JN, Tuan TC, Chao TF, Te ALD, Kuo L, Vicera JJB, Chang TY, Salim S, Chien KL, Chen SA. Comparison of phase mapping and electrogram-based driver mapping for catheter ablation in atrial fibrillation. Pacing Clin Electrophysiol. 2019 Feb;42(2):216-223. doi: 10.1111/pace.13573. Epub 2018 Dec 27.
- Derived from this study: PubMed 37991761Lin CY, Lin YJ, Higa S, Tsai WC, Lo MT, Chiang CH, Chang SL, Lo LW, Hu YF, Chao TF, Chung FP, Liao JN, Chang TY, Lin C, Tuan TC, Kuo L, Wu CI, Liu CM, Liu SH, Kuo MJ, Liao YC, Chuang CM, Chen YY, Hsieh YC, Chen SA. Catheter Ablation With Morphologic Repetitiveness Mapping for Persistent Atrial Fibrillation. JAMA Netw Open. 2023 Nov 1;6(11):e2344535. doi: 10.1001/jamanetworkopen.2023.44535.
- Individual participant dataSharing planned: No. The patient's data was available to the host of IRB.
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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.
Yenn-Jiang Lin, MD, PhD principal investigator
Director of Cardiology Division of Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation and Substrate ablation(PRISM based) in people with Atrial Fibrillation, Persistent, 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 4 inclusion and 7 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 6 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hsin Chiang (+886-2-28712121 ext. 1189, qqsnoopy0223@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (time frame: Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05333952, which also lists 4 linked publications.
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 6 Jun 2022.