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

Exploring the Relationship Between Duration of the Amplified P-Wave Arrhythmia and Recurrence in Patients With Persistent, Long Persistent or Paroxysmal AF Undergoing Cryoablation

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation Recurrent
• Intervention / Treatment: Diagnostic test: P-wave duration measurement on 12 lead ECG with standard parameters

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Guy Haywood, MBBD,MD; Phone Number: 07785955893; Email: guyhaywood@nhs.net

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL68DH
      • Recruiting
      • Univeristy Hospital Plymouth
      • Contact: Guy Haywood; Phone Number: 07785955893; Email: guyhaywood@nhs.net
      • Contact: Chris Rollinson; Phone Number: 07870636429; Email: CROLLINSON@NHS.NET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nik Spinthakis
• Collaborators: Dr Guy Haywood

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Anticipated): January 13, 2022
• Study Completion (Anticipated): May 13, 2023

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cryoablation; AF; P-wave duration
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: IRAS 287263-Local21/CAR/492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

To comply with the Data Protection legislation information must be collected and used fairly, stored safely and not disclosed to any unauthorised person. This applies to both manual and electronically held data.

The Chief Investigator will preserve the confidentiality of participants taking part in the study and ensure the EU General Data Protection Regulation (GDPR) in conjunction with the UK Data Protection Act 2018, which sets out the statutory requirements for the processing of personal data, is adhered to.

Study documents will be anonymised by allocation of a study number, and will not contain personal identifiable data. Finalised data in an anonymised electronic format will be sent via encrypted USB devices in order to be analysed in a password protected computer. For each patient, a study number will be allocated, and data entered on an anonymised electronic CRF (case report form) in the way of an excel spreadsheet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No