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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| PV reconnection ablation only | Active Comparator | Patients undergoning PV reconnection checking and ablation only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Burden of atrial arrhythmias | Arrhythmic burden (average percentage of time in AF/AT in 24h Holter) | up to 12 moths |
| incidence of periprocedural complications (pericardial effusion) | incidence of periprocedural complications such as pericardial effusion |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of intramyocardial fat (inFAT) into the HSC points | Concentration of intramyocardial fat (inFAT) into the atrial area where we found the HSC points | up to 12 months |
| Procedure features | procedure time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Berruezo Sanchez, MD, PHD | Contact | 3384090290 | antonio.berruezo@quironsalud.es |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748210 | Result | 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. | |
| 38011712 |
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This is a two-arm, single-center, randomized controlled trial
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|
| 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). |
|
| up to 12 months |
| Use of antiarrhythmic drugs | Use of antiarrhythmic drugs after the blanking period of 60 days. | up to 12 months |
| incidence of periprocedural complications (peripheral complication) | incidence of periprocedural complications such as peripheral complication | up to 12 moths |
| incidence of periprocedural complications (transient ischemic attack or stroke) | incidence of periprocedural complications such as transient ischemic attack or stroke | up to 12 months |
| up to 12 months |
| Atrial arrhythmias first recurrence | Evaluation of the atrial arrhythmias recurrence in patients with isolated PVs underwent HSC sites ablation | up to 12 months |
| Left atrial wall thickness (LAWT) measurement into the HSC points | Left atrial wall thickness (LAWT) measurement into the atrial areas where we found the HSC points | up to 12 months |
| procedure features | fluoroscopy time | up to 12 months |
| procedure features | fluoroscopy dose | up to 12 months |
| procedure features | number of radiofrequency (RF) applications | up to 12 months |
| procedure times | radiofrequency (RF) total delivery time | up to 12 months |
| 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. |
| 37961921 | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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