P-wave Terminal Force in Patients With Atrial Fibrillation.

• Conditions: Atrial Fibrillation

• Registration Number: NCT03428971
• Lead Sponsor: Medical University of Lublin

Brief Summary

It is suggested that P-wave terminal force (Ptf), a product of the amplitude (PAM) and the duration (PT) of the terminal phase of P-wave in lead V1, shows early delay in left atrial conduction, observed earlier that the dilatation of left atrium.

The aim is to follow PT, PAM and Ptf changes during 5-year follow-up (5FU) and examine the relation of these changes to the number of AF episodes requiring hospitalisation (HOSP) for restoration of sinus rhythm (RSR).

Detailed Description

Background. It is suggested that P-wave terminal force (Ptf), a product of the amplitude (PAM) and the duration (PT) of the terminal phase of P-wave in lead V1, shows early delay in left atrial conduction, observed earlier that the dilatation of left atrium.

Aim. We aim to follow PT, PAM and Ptf changes during 5-year follow-up (5FU) and examine the relation of these changes to the number of AF episodes requiring hospitalisation (HOSP) for restoration of sinus rhythm (RSR).

We hypothesise that, in patients with atrial fibrillation (AF):

1. the index parameters (PT, PAM, Ptf), characterising left atrial repolarization, correlates the number of future hospitalisations (HOSP) aimed for restoration of sinus rhythm (RSR) in 5-year follow-up (5FU)

2. in 5FU the number of HOSP aimed for RSR correlates with the progression of left atrium electrical remodelling, expressed as PAM5,PT5, Ptf5 at 5FU.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-12
• Study Start: 2018-03-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-22
• Primary Completion: 2020-03-07
• Study Completion: 2020-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• documented atrial fibrillation at admission
• successful restoration of sinus rhythms documented in 12-leads ECG,
• follow-up => 5 years

Exclusion Criteria

• arrhythmia other than atrial fibrillation at admission,
• unsuccessful restoration of sinus rhythms,
• successful restoration of sinus rhythms but missing 12-leads ECG recording,
• previous ablation/operation within left atrium,
• follow-up < 5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of P-wave time (PT), P-wave amplitude (PAM) and Ptf (P wave terminal force terminal V1-lead ) in 5-year follow-up (5FU).	5 years	All measurements based on ECG recording during sinus rhythm only.; * "P-wave time (PT)" defined as time (measured in milliseconds, \[ms\]) of negative deflection of P wave in V1 lead of the standard 12-lead ECG; * "P-wave amplitude (PAM)" defined as maximum amplitude (measured in millivolts, \[mV\]) of negative deflection of P wave in V1 lead of the standard 12-lead ECG; * "P-wave terminal force (Ptf)" is a product of the amplitude and the duration of the terminal phase of P-wave in lead V1; Ptf = PT x PAM \[ms x mV\]; * PT and PAM measured at index is defined as PT0 and PAM0, respectively; * Calculated Ptf as a product of PT0 and PAM0 is defined as Ptf0; * PT and PAM measured at 5FU is defined as PT5 and PAM5, respectively; * Calculated Ptf as a product of PT5 and PAM5 is defined as Ptf5; * The change between PT0 and PT5 (PTC = PT5 - PT0) , PAM0 and PAM5 (PAMC = PAM5 - PAM0), Ptf0 and Ptf5 (PtfC = Ptf5 - Ptf0) will be calculated for each patient;

Secondary Outcome Measures

Name	Time	Method
Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up	5 years	Statistical analysis of Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up
Correlation between number of hospitalizations (HOSP) in 5- year follow-up and final PT5, PAM5, Ptf5 at the end of 5-year follow-up period.	5 years	Statistical analysis of Correlation between number of hospitalizations (HOSP) in 5- year follow-up and final PT5, PAM5, Ptf5 at the end of 5-year follow-up period.
Correlation between changes of PT, PAM, Ptf (PTC, PAMC, PtfC) and number of hospitalizations (HOSP) in 5-year follow-up.	5 years	Statistical analysis of Correlation between changes of PTC, PAMC, PtfC and number of hospitalizations (HOSP) in 5-year follow-up.

Trial Locations

Locations (1)

Medical University of Lublin; 🇵🇱 Lublin, Poland