P-wave Terminal Force in Patients With Atrial Fibrillation.

NCT03428971 | Unknown

• 1 other identifier: MW-MULublin-1
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; p-wave; hospitalization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up

  5 years

• 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

• Correlation between changes of PT, PAM, Ptf (PTC, PAMC, PtfC) and number of hospitalizations (HOSP) in 5-year follow-up.

  5 years

Interventions

cardioversion PROCEDURE

Direct current (DC) cardioversion for sinus rhythm restoration

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Medical University of Lublin

Lublin, 20-091, Poland

RECRUITING

Related Publications (4)

• 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.

  PMID: 22465604 BACKGROUND

• 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.

  PMID: 20374516 BACKGROUND

• 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.

  PMID: 20133209 BACKGROUND

• 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.

  PMID: 21803476 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Maciej Wójcik, MD, PhD

  Medical University of Lublin, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Wójcik, MD, PhD

CONTACT

+48817244151; m.wojcik@umlub.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 12, 2018
• Study Start: March 1, 2018
• Primary Completion: March 7, 2020
• Study Completion: December 7, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

PL (1)