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

• Sponsor: Nik Spinthakis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04968678
• Collaborator: Dr Guy Haywood (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Recurrent	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Exploring the Relationship Between Duration of the Amplified P-Wave Arrhythmia and Recurrence in Patients With Persistent, Long Persistent or Paroxysmal AF Undergoing Cryoablation
• Actual Study Start Date: May 13, 2021
• Anticipated Primary Completion Date: Jan 13, 2022
• Anticipated Study Completion Date: May 13, 2023

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy Hospital Plymouth	Plymouth	Devon	United Kingdom	PL68DH

Sponsors and Collaborators

• Nik Spinthakis
• Dr Guy Haywood

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nik Spinthakis, PI,Cardiology ST5,MBBS,MRCP,MD, University Hospital Plymouth NHS Trust
• ClinicalTrials.gov Identifier: NCT04968678
• Other Study ID Numbers: IRAS 287263-Local21/CAR/492
• First Posted: Jul 20, 2021
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nik Spinthakis, PI,Cardiology ST5,MBBS,MRCP,MD, University Hospital Plymouth NHS Trust: P-wave duration; AF; cryoablation
• Additional relevant MeSH terms: Atrial Fibrillation; Recurrence

Study Results

No Results Posted as of Jul 20, 2021