Clinical trial NCT03428971: P-wave Terminal Force in Patients With Atrial Fibrillation.
Official title: P-wave Terminal Force in Patients With Atrial Fibrillation: Can we Predict Number of Hospitalisations and Left Atrial Electrical Remodelling? - Ptf-AF Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
p-wave
hospitalization
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation admitted between 1.1.2001 and 30.12.2012 for elective and emergency hospitalization aimed for restoration of sinus rhythms with DC cardioversion.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 5 years
Secondary outcomes:
measure: Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: Correlation between changes of PT, PAM, Ptf (PTC, PAMC, PtfC) and number of hospitalizations (HOSP) in 5-year follow-up.
timeFrame: 5 years
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
affiliation: Medical University of Lublin, Poland
name: Maciej Wójcik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wojcik M, Kuniss M, Berkowitsch A, Neumann T. P-wave terminal force and atrial fibrillation: a lesson learned from old masters. Rev Esp Cardiol (Engl Ed). 2012 Jun;65(6):584-5; author reply 585. doi: 10.1016/j.recesp.2012.01.015. Epub 2012 Mar 31. No abstract available.
citation: Janin S, Wojcik M, Kuniss M, Berkowitsch A, Erkapic D, Zaltsberg S, Ecarnot F, Hamm CW, Pitschner HF, Neumann T. Pulmonary vein antrum isolation and terminal part of the P wave. Pacing Clin Electrophysiol. 2010 Jul;33(7):784-9. doi: 10.1111/j.1540-8159.2010.02754.x. Epub 2010 Mar 29.
citation: Ishida K, Hayashi H, Miyamoto A, Sugimoto Y, Ito M, Murakami Y, Horie M. P wave and the development of atrial fibrillation. Heart Rhythm. 2010 Mar;7(3):289-94. doi: 10.1016/j.hrthm.2009.11.012. Epub 2009 Nov 12.
citation: Martin Garcia A, Jimenez-Candil J, Hernandez J, Martin Garcia A, Martin Herrero F, Martin Luengo C. P wave morphology and recurrence after cardioversion of lone atrial fibrillation. Rev Esp Cardiol (Engl Ed). 2012 Mar;65(3):289-90. doi: 10.1016/j.recesp.2011.04.023. Epub 2011 Jul 30. No abstract available. English, Spanish.