NCT05169320: TAILOR-AF

Patient-TAILORed Ablation of Persistent AF Guided by Instantaneous Amplitude and Frequency Modulation Maps (TAILOR-AF)

Status unknown Last updated 7 August 2023

What this trial tests

trial testing Subcutaneous implantable loop recorder (ILR) implantation in Persistent Atrial Fibrillation in 25 participants. Status unknown.

Timeline

1 December 2021

Primary endpoint
30 June 2024

30 December 2024

Quick facts

Lead sponsor	Hospital San Carlos, Madrid
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	25
Start date	1 December 2021
Primary completion	30 June 2024
Estimated completion	30 December 2024
Sites	2 locations across Spain

Drugs / interventions tested

• Subcutaneous implantable loop recorder (ILR) implantation
• Mapping and catheter ablation
• Minimally invasive surgical ablation via thoracoscopy

Conditions studied

• Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →

Sponsor

Hospital San Carlos, Madrid

Who can join

Adults 18 to 75, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pulmonary vein isolation (PVI) is still considered the cornerstone of catheter ablation for patients with persistent atrial fibrillation (AF). However, ablation outcomes in patients with persistent AF are suboptimal with high recurrence rates after a single PVI procedure.

Recently, the investigators developed a new strategy, which enables precise identification of the driver regions allegedly responsible for the maintenance of persistent AF outside the pulmonary veins. This approach uses a conventional electroanatomical mapping system and novel single-signal algorithms based on automatic and accurate analysis of the instantaneous amplitude and frequency modulations displayed by atrial signals during AF (iAM and iFM, respectively) to locate the spatiotemporally stable regions that drive persistent AF (leading drivers).

This strategy also enables to identify highly complex substrates in which targeting leading driver regions with catheter-based ablation may not be feasible or could be potentially associated with a significantly higher risk of complications. In such patients, the iAM/iFM maps obtained in the index catheter mapping and ablation procedure will be used to guide an additional patient-specific, minimally invasive surgical ablation approach via thoracoscopy, aiming to completely but specifically target all leading driver regions.

The main objective of the TAILOR-AF study is to identify (via iAM/iFM maps), target and ablate AF leading drivers in patients with symptomatic persistent AF recurrences despite ≥2 previous PVI procedures. The methods include a percutaneous catheter mapping and ablation approach followed by a minimally invasive surgical approach via thoracoscopy, if necessary. As a secondary objective we will study the association of underlying blood biomarkers, atrial imaging and surface ECG parameters, with advanced remodeling stages requiring a surgical approach to target leading driver regions.

This is a single center study (Hospital Clínico San Carlos, Madrid, Spain) that will recruit 25 patients with symptomatic persistent AF episodes despite having been submitted to ≥2 PVI prior procedures. All patients will undergo subcutaneous implantable loop recorder (ILR) implantation to address AF burden 1 month before the ablation procedure and at least 1 year after the ablation procedure. The primary outcome of the study will be AF freedom after one year of follow-up off antiarrhythmic drugs.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transforming atrial fibrillation management by targeting comorbidities and reducing atrial fibrillation burden: the 10th AFNET/EHRA consensus conference.
   Svennberg E, Merino JL, Andrade J, Anselmino M, et al · · 2025 · cited 5× · PMID 41392710 · DOI 10.1093/europace/euaf318
2. Surgical ablation of atrial fibrillation with concomitant cardiac surgery: a state-of-the-art review.
   Kowalewski M, Dąbrowski EJ, Kurasz A, Święczkowski M, et al · · 2025 · cited 4× · PMID 40574669 · DOI 10.1093/ejcts/ezaf187