Exploring P-Wave Duration in Arrhythmia Recurrence in Patients Undergoing AF Ablation

• Conditions: Atrial Fibrillation Recurrent

• Registration Number: NCT04968678
• Lead Sponsor: Nik Spinthakis

Brief Summary

The aim of this study is to investigate whether P-wave duration in a baseline surface 12-lead ECGs correlates with recurrence of AF recurrence post successful ablation at the time of the procedure.

Detailed Description

Patients with paroxysmal AF are often treated arrhythmia-free (75%) with a single catheter ablation at 12 months post procedure . In contrast, in patients with persistent AF or long persistent AF, catheter ablation is more complex and often yields in lower success rates of around 50% often requiring multiple attempts .

The success rates remain low despite several different ablation sites having been proposed (additional lines plus PVI, epicardial approach).

There is growing evidence that PWD is associated with the extent of left atrial scarring and this can be used a potential predictor of AF recurrence . Moreover, results from the investigators group has previously shown that PWD correlated with the duration of the AF and this could be altered by extensive ablation .

It is uncertain whether PWD prior to any procedure for persistent AF, long persistent or paroxysmal AF can accurately predict failure of procedure.

This is a single centre observational study of persistent, long persistent and paroxysmal AF population who have undergo AF cryoablation in University Hospital Plymouth . All patients receive this current procedure as standard of care.

This study does not involve any patient contact out of the standard routine clinical follow up and therefore no public involvement has been sought.

Study Timeline

• Study Start: 2021-05-13
• Study First Submitted: 2021-06-26
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20
• Primary Completion: 2022-01-13
• Study Completion: 2023-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with persistent, long persistent or paroxysmal AF undergone AF cryoablation from 2016 onwards
2. Age >18
3. Patient does not meet exclusion criteria -

Exclusion Criteria

1. Patients whose records cannot be obtained
2. Patients with persistent, long persistent or paroxysmal AF undergone AF ablation prior to 2016
3. Patients with no documented ECG in sinus rhythm prior to ablation
4. Patients not undergoing cryoablation for AF -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial fibrillation.	24 months	Primary.This will be documented in a 12 lead ECG \>30sec post ablation according to standard operation procedures follow up. Patients are actively followed up in regular intervals (4-12-24 months) post procedure and are able to contact department for advise if clinically suspected recurrence of atrial fibrillation. This is well studied and documented in previous studies as an outcome of measure.

Trial Locations

Locations (1)

Univeristy Hospital Plymouth; 🇬🇧 Plymouth, Devon, United Kingdom