NCT05396534

Brief Summary

The investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol for persistent AF ablation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

May 25, 2022

Last Update Submit

August 29, 2023

Conditions

Persistent Atrial FibrillationPersistent Atrial Fibrillation Longstanding

Keywords

Atrial FibrillationCatheter AblationMultidetector Computed TomographyPersistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia-free survival

    The efficacy primary endpoint will be survival free of any atrial arrhythmia at12-month follow-up visits. From this endpoint, important definitions must be taken into account: AF clinical recurrence will be considered only after the 3-month 'blanking period'.

    After the 3-month 'blanking period' for 12 month

Secondary Outcomes (3)

  • Procedure time

    intraprocedural outcome

  • Radiofrequency time

    intraprocedural outcome

  • Number of application

    intraprocedural outcome

Study Arms (2)

byLAWT arm

EXPERIMENTAL

Personalized protocol that uses a contact-force catheter, a multichannel radiofrequency generator, and integrated MDCT-derived Left Atrial Wall Thickness (LAWT) information to adapt the ablation index target to the subjacent LAWT.

Procedure: Atrial Fibrillation transcatheter ablation

CLOSE arm

ACTIVE COMPARATOR

In the CLOSE arm, the use of MDCT-derived LAWT information will not be available for the operator. We uses a contact-force catheter. Ablation will be performed according to the CLOSE study settings: Power-controlled mode (without ramping) with 25 to 35 W (irrigation flow 30 ml/min). RF will be delivered until an AI of 400 at the posterior wall/roof an 550 at the anterior wall are reached.

Procedure: Atrial Fibrillation transcatheter ablation

Interventions

Atrial Fibrillation transcatheter ablationPROCEDURE

We perform pulmonary veins isolation that remains remains the cornerstone of all catheter-based treatment strategies in atrial fibrillation

CLOSE armbyLAWT arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years.
  • Indication for persistent atrial fibrillation ablation.
  • Signed informed consent

You may not qualify if:

  • Age \< 18 years.
  • Pregnancy.
  • Previous AF redo procedure.
  • Impossibility to perform a pre-procedural CT scan.
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teknon Medical Center

Barcelona, 08022, Spain

RECRUITING

Related Publications (6)

  • Teres C, Soto-Iglesias D, Penela D, Jauregui B, Ordonez A, Chauca A, Carreno JM, Scherer C, San Antonio R, Huguet M, Roque A, Ramirez C, Oller G, Jornet A, Palet J, Santana D, Panaro A, Maldonado G, de Leon G, Jimenez G, Evangelista A, Carballo J, Ortiz-Perez JT, Berruezo A. Personalized paroxysmal atrial fibrillation ablation by tailoring ablation index to the left atrial wall thickness: the 'Ablate by-LAW' single-centre study-a pilot study. Europace. 2022 Mar 2;24(3):390-399. doi: 10.1093/europace/euab216.

    PMID: 34480548RESULT

  • Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, Debonnaire P, Wolf M, Vandekerckhove Y, Knecht S, Tavernier R. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020 Apr;17(4):535-543. doi: 10.1016/j.hrthm.2019.11.004. Epub 2019 Nov 9.

    PMID: 31707159RESULT

  • Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27.

    PMID: 29600792RESULT

  • Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.

    PMID: 30354288RESULT

  • Falasconi G, Penela D, Soto-Iglesias D, Latini AC, Landra F, Curti E, Francia P, Saglietto A, Turturiello D, Viveros D, Bellido A, Alderete J, Zaraket F, Franco-Ocana P, Valcher S, Amata F, Valeriano C, Gigante C, Teresi L, Tonello B, Mea R, Sanchez-Molla L, De Lucia C, Huguet M, Camara O, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein isolation guided by left atrial wall thickness for persistent atrial fibrillation ablation: the PeAF-by-LAWT randomized trial. Europace. 2025 Dec 1;27(12):euaf163. doi: 10.1093/europace/euaf163.

    PMID: 40794635DERIVED

  • Falasconi G, Penela D, Soto-Iglesias D, Francia P, Teres C, Saglietto A, Jauregui B, Viveros D, Bellido A, Alderete J, Meca-Santamaria J, Franco P, Gaspardone C, San Antonio R, Huguet M, Camara O, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein antrum isolation guided by left atrial wall thickness for persistent atrial fibrillation. Europace. 2023 May 19;25(5):euad118. doi: 10.1093/europace/euad118.

    PMID: 37125968DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Berruezo, MD, PhD

CONTACT

669761263antonio.berruezo@quironsalud.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, single-blind, single-center, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Arrhythmia Department

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

July 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2024

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

ES(1)