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

NCT04968678 | Unknown DMC

• 1 other identifier: IRAS 287263-Local21/CAR/492
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation Recurrent

Keywords

P-wave duration; AF; cryoablation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation.

  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.

  24 months

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective single centre study of the investigators current registry of patients undergoing AF ablation from existing clinical procedural database which contains a record of all cryoablation performed within the hospital. All records once obtained from the main database, will then be uploaded into a password protected Excel spreadsheet and anonymised at the time of entry by the ICI.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nik Spinthakis: lead
• Dr Guy Haywood: collaborator

Study Sites (1)

Univeristy Hospital Plymouth

Plymouth, Devon, PL68DH, United Kingdom

RECRUITING

Central Study Contacts

Guy Haywood, MBBD,MD

CONTACT

07785955893; guyhaywood@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI,Cardiology ST5,MBBS,MRCP,MD

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 20, 2021
• Study Start: May 13, 2021
• Primary Completion: January 13, 2022
• Study Completion: May 13, 2023
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

GB (1)