P-wave Terminal Force in Patients With Atrial Fibrillation. (Ptf-AF)

January 20, 2020 updated by: Maciej Wójcik, MD, PhD, Medical University of Lublin

P-wave Terminal Force in Patients With Atrial Fibrillation: Can we Predict Number of Hospitalisations and Left Atrial Electrical Remodelling? - Ptf-AF Trial

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lublin, Poland, 20-091
        • Recruiting
        • Medical University of Lublin
        • Sub-Investigator:
          • Robert Błaszczyk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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;
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between index PT0, PAM0, Ptf0 and number of hospitalizations (HOSP) in 5-year follow-up
Time Frame: 5 years
Statistical analysis of 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.
Time Frame: 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.
5 years
Correlation between changes of PT, PAM, Ptf (PTC, PAMC, PtfC) and number of hospitalizations (HOSP) in 5-year follow-up.
Time Frame: 5 years
Statistical analysis of Correlation between changes of PTC, PAMC, PtfC and number of hospitalizations (HOSP) in 5-year follow-up.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

March 7, 2020

Study Completion (Anticipated)

December 7, 2020

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 20, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MW-MULublin-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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