P-wave Terminal Force in Patients With Atrial Fibrillation.

Atrial Fibrillation Clinical Trial

— Ptf-AF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428971
• Other study ID #: MW-MULublin-1
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: December 7, 2020

Study information

• Verified date: January 2020
• Source: Medical University of Lublin
• Contact: Maciej Wójcik, MD, PhD
• Phone: +48817244151
• Email: m.wojcik[@]umlub.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 7, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• cardioversion
Direct current (DC) cardioversion for sinus rhythm restoration

Locations

Country	Name	City	State
Poland	Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View 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. — View Citation

Martín García A, Jiménez-Candil J, Hernández J, Martín García A, Martín Herrero F, Martín 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. English, Spanish. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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;	5 years
Secondary	Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up	Statistical analysis of Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up	5 years
Secondary	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.	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.	5 years
Secondary	Correlation between changes of PT, PAM, Ptf (PTC, PAMC, PtfC) and number of hospitalizations (HOSP) in 5-year follow-up.	Statistical analysis of Correlation between changes of PTC, PAMC, PtfC and number of hospitalizations (HOSP) in 5-year follow-up.	5 years