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

NCT ID: NCT04968678

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-13

Study Completion Date

2023-05-13

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Recurrent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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P-wave duration measurement on 12 lead ECG with standard parameters

Hospital records will be used in order to obtain baseline characteristics and the most recent 12-lead ECG in sinus rhythm prior to ablation will be used to calculate PWD. Measurement of the PWD will be obtained at standard surface ECG recording settings of 25mm/s and 10mm/mV and measured accordingly to our previous protocol. In brief, all ECGs obtained will subsequently be anonymised and randomised by an Independent Clinical Investigator (ICI) before measured by the main clinical investigators blinded to initial results. If a dispute of the measurements arouse, consensus will be used to resolve it after consulting the Chief Investigator (CI) blinded to the results. Bland-Altman plots to minimise bias will be used

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with persistent, long persistent or paroxysmal AF undergone AF cryoablation from 2016 onwards
2. Age \>18

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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Guy Haywood

UNKNOWN

Sponsor Role collaborator

Nik Spinthakis

OTHER

Sponsor Role lead

Responsible Party

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Nik Spinthakis

PI,Cardiology ST5,MBBS,MRCP,MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Univeristy Hospital Plymouth

Plymouth, Devon, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Guy Haywood, MBBD,MD

Role: CONTACT

07785955893

Facility Contacts

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Guy Haywood

Role: primary

07785955893

Chris Rollinson

Role: backup

07870636429

Other Identifiers

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IRAS 287263-Local21/CAR/492

Identifier Type: -

Identifier Source: org_study_id

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