Atrial FibrillationNCT06657170
Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate (Unmask-AF)
A study testing Pulmunary veins reconnection plus hidden slow conduction ablation and Pulmunary veins (PV) reconnection ablation only in people with Atrial Fibrillation, run by Centro Medico Teknon.
Trial summary
Over recent years, pulmonary vein isolation (PVI) procedures have demonstrated progressively enhanced efficacy and safety, resulting in a substantial increase in the number of atrial fibrillation ablations, not only as a first-line treatment but also for repeat procedures. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmunary veins reconnection plus hidden slow conduction ablation and Pulmunary veins (PV) reconnection ablation only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Sep 2027
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent paroxysmal AF (continuous AF episode lasting longer than 30 s but terminating spontaneously or with intervention within 7 days of onset), recurrent persistent AF (continuous AF episode lasting longer than 7 days but < 1 year) and recurrent long standing persistent AF (continuous AF ≥1 year in duration, in patients where rhythm control management is being pursued)
- Previous PVI procedure
- Age > 40 years
- Willing and capable of providing consent
- Able and willing to comply with all follow-up testing and requirements
Who cannot join
- Additional left atrial ablations during the previous procedures (es. posterior wall isolation, anterior line, roof line, CFAE and others)
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Severe mitral regurgitation
- Women who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
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
Official title: Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate
Over recent years, pulmonary vein isolation (PVI) procedures have demonstrated progressively enhanced efficacy and safety, resulting in a substantial increase in the number of atrial fibrillation ablations, not only as a first-line treatment but also for repeat procedures. However, there is still a notable lack of randomized evidence in this area, which limits guidance and decision-making in clinical practice. Recently, the investigators found that employing short-coupled atrial extrastimuli revealed highly fragmented or double atrial evoked electrograms (EGMs) in AF patients, termed as hidden slow conduction (HSC). Identifying HSC sites may provide insight into the early identification of the arrhythmogenic substrate, offering a potential target for ablation This multi-center, prospective, randomized, controlled trial will include two arms: one investigational (PV reconnection + HSC) and one control (PV reconnection). All the subjects will be followed for 12 months after the ablation procedure.
The aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures. The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmunary veins reconnection plus hidden slow conduction ablation, Pulmunary veins (PV) reconnection ablation only
- Keywords
- Catheter Ablation, Re-do Procedures, Hidden Slow Conduction, Functional Substrate 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.
Pulmunary veins reconnection plus hidden slow conduction ablationProcedure or surgery
Ablation of pulmonary veins reconnections plus the search and ablation of hidden slow conductions sites (HSC) in the left atrium.
HSC sites are defined as EGMs showing highly fragmented or double electrograms in response atrial triple extrastimulus, presenting normal or fractionated electrogram in the sinus rhythm.
After checking for PV's conduction breakthroughs, point-by point ablation targeting HSC-EGMs will be performed.
The end point for HSC+ ablation will be reached with loss of local capture at a given lesion, pacing from the ablation catheter at high output (10V·2ms).
Pulmunary veins (PV) reconnection ablation onlyProcedure or surgery
Each vein will be re-assessed by observing PV potentials along the PV ostia and by pacing from the distal bipole of the ablation catheter (10mA at 2ms) within the lesion set with failed capture of the left atrium. In case of PVs reconnection touch-up applications will be performed at the earliest potential site, identified by comparing far-field atrial EGM to near-field local EGM timing, until isolation will be achieved (entrance and exit block).
| Study group | Role | What they receive |
|---|---|---|
| PV reconnection + HSC ablation | Experimental | Patients undergoning pulmunary veins (PV) reconnection checking and ablation plus identification and ablation of hidden sites of slow conduction (HSC) Receives: Procedure: Pulmunary veins reconnection plus hidden slow conduction ablation |
| PV reconnection ablation only | Active comparator | Patients undergoning PV reconnection checking and ablation only. Receives: Procedure: Pulmunary veins (PV) reconnection ablation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial arrhythmias recurrence
The primary endpoint of the study aims to establish the impact of targeting HSC sites alongside PV gaps in repeat ablation procedures for patients with recurrent AF. Specifically evaluating the freedom from atrial tachyarrhythmia recurrence (documented AF/AT/AFL lasting at least 30s).
Measured: up to 12 moths
Secondary outcomes (5)
Burden of atrial arrhythmias
Arrhythmic burden (average percentage of time in AF/AT in 24h Holter)
Measured: up to 12 moths
incidence of periprocedural complications (pericardial effusion)
incidence of periprocedural complications such as pericardial effusion
Measured: up to 12 months
Use of antiarrhythmic drugs
Use of antiarrhythmic drugs after the blanking period of 60 days.
Measured: up to 12 months
incidence of periprocedural complications (peripheral complication)
incidence of periprocedural complications such as peripheral complication
Measured: up to 12 moths
incidence of periprocedural complications (transient ischemic attack or stroke)
incidence of periprocedural complications such as transient ischemic attack or stroke
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, single-center, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657170
- Sponsor's protocol ID
- Unmask-AF
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7.
PubMed 23748210Saglietto A, Falasconi G, Soto-Iglesias D, Francia P, Penela D, Alderete J, Viveros D, Bellido AF, Franco-Ocana P, Zaraket F, Turturiello D, Marti-Almor J, Berruezo A. Assessing left atrial intramyocardial fat infiltration from computerized tomography angiography in patients with atrial fibrillation. Europace. 2023 Dec 6;25(12):euad351. doi: 10.1093/europace/euad351.
PubMed 38011712Silva Garcia E, Lobo-Torres I, Fernandez-Armenta J, Penela D, Fernandez-Garcia M, Gomez-Lopez A, Soto-Iglesias D, Fernandez-Rivero R, Vazquez-Garcia R, Acosta J, Bisbal F, Cano-Calabria L, Berruezo A. Functional mapping to reveal slow conduction and substrate progression in atrial fibrillation. Europace. 2023 Nov 2;25(11):euad246. doi: 10.1093/europace/euad246.
PubMed 37961921
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate
- ClinicalTrials.gov ID
- NCT06657170
- Acronym / sponsor ID
- Unmask-AF
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter Ablation, Re-do Procedures, Hidden Slow Conduction, Functional Substrate Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 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.
Over recent years, pulmonary vein isolation (PVI) procedures have demonstrated progressively enhanced efficacy and safety, resulting in a substantial increase in the number of atrial fibrillation ablations, not only as a first-line treatment but also for repeat procedures. However, there is still a notable lack of randomized evidence in this area, which limits guidance and decision-making in clinical practice. Recently, the investigators found that employing short-coupled atrial extrastimuli revealed highly fragmented or double atrial evoked electrograms (EGMs) in AF patients, termed as hidden slow conduction (HSC). Identifying HSC sites may provide insight into the early identification of the arrhythmogenic substrate, offering a potential target for ablation This multi-center, prospective, randomized, controlled trial will include two arms: one investigational (PV reconnection + HSC) and one control (PV reconnection). All the subjects will be followed for 12 months after the ablation procedure.
The aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures. The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, single-center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PV reconnection + HSC ablation | Experimental | Procedure: Pulmunary veins reconnection plus hidden slow conduction ablationPatients undergoning pulmunary veins (PV) reconnection checking and ablation plus identification and ablation of hidden sites of slow conduction (HSC) |
| PV reconnection ablation only | Active comparator | Procedure: Pulmunary veins (PV) reconnection ablation onlyPatients undergoning PV reconnection checking and ablation only. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recurrent paroxysmal AF (continuous AF episode lasting longer than 30 s but terminating spontaneously or with intervention within 7 days of onset), recurrent persistent AF (continuous AF episode lasting longer than 7 days but < 1 year) and recurrent long standing persistent AF (continuous AF ≥1 year in duration, in patients where rhythm control management is being pursued)
- Previous PVI procedure
- Age > 40 years
- Willing and capable of providing consent
- Able and willing to comply with all follow-up testing and requirements
Key exclusion criteria (5 listed)
- Additional left atrial ablations during the previous procedures (es. posterior wall isolation, anterior line, roof line, CFAE and others)
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Severe mitral regurgitation
- Women who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
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 |
|---|---|---|
| Pulmunary veins reconnection plus hidden slow conduction ablationAblation of pulmonary veins reconnections plus the search and ablation of hidden slow conductions sites (HSC) in the left atrium. HSC sites are defined as EGMs showing highly fragmented or double electrograms in response atrial triple extrastimulus, presenting normal or fractionated electrogram in the sinus rhythm. After checking for PV's conduction breakthroughs, point-by point ablation targeting HSC-EGMs will be performed. The end point for HSC+ ablation will be reached with loss of local capture at a given lesion, pacing from the ablation catheter at high output (10V·2ms). | Procedure or surgery | PV reconnection + HSC ablation |
| Pulmunary veins (PV) reconnection ablation onlyEach vein will be re-assessed by observing PV potentials along the PV ostia and by pacing from the distal bipole of the ablation catheter (10mA at 2ms) within the lesion set with failed capture of the left atrium. In case of PVs reconnection touch-up applications will be performed at the earliest potential site, identified by comparing far-field atrial EGM to near-field local EGM timing, until isolation will be achieved (entrance and exit block). | Procedure or surgery | PV reconnection ablation only |
Primary outcome
Atrial arrhythmias recurrence
Time frame: up to 12 moths
The primary endpoint of the study aims to establish the impact of targeting HSC sites alongside PV gaps in repeat ablation procedures for patients with recurrent AF. Specifically evaluating the freedom from atrial tachyarrhythmia recurrence (documented AF/AT/AFL lasting at least 30s).
5 secondary outcomes
Burden of atrial arrhythmias
Time frame: up to 12 moths
incidence of periprocedural complications (pericardial effusion)
Time frame: up to 12 months
Use of antiarrhythmic drugs
Time frame: up to 12 months
incidence of periprocedural complications (peripheral complication)
Time frame: up to 12 moths
incidence of periprocedural complications (transient ischemic attack or stroke)
Time frame: up to 12 months
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 12 Dec 2024.
- Results publication: PubMed 23748210Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7.
- Results publication: PubMed 38011712Saglietto A, Falasconi G, Soto-Iglesias D, Francia P, Penela D, Alderete J, Viveros D, Bellido AF, Franco-Ocana P, Zaraket F, Turturiello D, Marti-Almor J, Berruezo A. Assessing left atrial intramyocardial fat infiltration from computerized tomography angiography in patients with atrial fibrillation. Europace. 2023 Dec 6;25(12):euad351. doi: 10.1093/europace/euad351.
- Results publication: PubMed 37961921Silva Garcia E, Lobo-Torres I, Fernandez-Armenta J, Penela D, Fernandez-Garcia M, Gomez-Lopez A, Soto-Iglesias D, Fernandez-Rivero R, Vazquez-Garcia R, Acosta J, Bisbal F, Cano-Calabria L, Berruezo A. Functional mapping to reveal slow conduction and substrate progression in atrial fibrillation. Europace. 2023 Nov 2;25(11):euad246. doi: 10.1093/europace/euad246.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmunary veins reconnection plus hidden slow conduction ablation and Pulmunary veins (PV) reconnection ablation only in people with Atrial Fibrillation, run by Centro Medico Teknon.
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 5 inclusion and 5 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 12 Dec 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 Antonio Berruezo Sanchez, MD, PHD (3384090290, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial arrhythmias recurrence (time frame: up to 12 moths). 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 NCT06657170, which also lists 3 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 12 Dec 2024.