Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate (Unmask-AF)

NCT06657170 | Not Yet Recruiting DMC

• 1 other identifier: Unmask-AF
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Catheter Ablation; Re-do Procedures; Hidden Slow Conduction; Functional Substrate Ablation

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 12 moths

Secondary Outcomes (5)

• Burden of atrial arrhythmias

  up to 12 moths

• incidence of periprocedural complications (pericardial effusion)

  up to 12 months

• Use of antiarrhythmic drugs

  up to 12 months

• incidence of periprocedural complications (peripheral complication)

  up to 12 moths

• incidence of periprocedural complications (transient ischemic attack or stroke)

  up to 12 months

Other Outcomes (8)

• Concentration of intramyocardial fat (inFAT) into the HSC points

  up to 12 months

• Procedure features

  up to 12 months

• Atrial arrhythmias first recurrence

  up to 12 months

Study Arms (2)

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)

Procedure: Pulmunary veins reconnection plus hidden slow conduction ablation

PV reconnection ablation only

ACTIVE COMPARATOR

Patients undergoning PV reconnection checking and ablation only.

Procedure: Pulmunary veins (PV) reconnection ablation only

Interventions

Pulmunary veins reconnection plus hidden slow conduction ablation PROCEDURE

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).

PV reconnection + HSC ablation

Pulmunary veins (PV) reconnection ablation only PROCEDURE

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).

PV reconnection ablation only

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Medico Teknon: lead

Related Publications (3)

• 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.

  PMID: 23748210 RESULT

• Saglietto 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.

  PMID: 38011712 RESULT

• Silva 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.

  PMID: 37961921 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Berruezo Sanchez, MD, PHD

CONTACT

3384090290; antonio.berruezo@quironsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Electrophysiology unit

Model Details: This is a two-arm, single-center, randomized controlled trial

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: October 24, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12