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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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