Effect of Right Ventricle Lead Position on The Psychological Aspects of Patients With A Dual Chamber Pacemaker

August 18, 2023 updated by: Hassan El-Shirbiny, Kafrelsheikh University

Effect of Right Ventricle Lead Position on The Psychological Aspects of Patients With A Dual Chamber Pacemaker; A Prospective Comparative Controlled Study

The purpose of the current study was to determine the factors associated with increased levels of anxiety and depression both before and after pacemaker implantation and examine if changes in these symptoms occur during the first postoperative year.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Both clinical and experimental studies declared that RV pacing and the position of RV lead may lead to ventricular desynchrony, mimics that of LBBB with subsequent abnormal mechanical and electrical activation of the ventricles . This results in changes in cardiac perfusion, hemodynamics, metabolism and mechanical function .

With time, RV pacing may also lead to LV remodeling and structural changes . Also, it has been mentioned that the presence of mechanical desynchrony after long-term RV pacing especially the apical one is linked with reduced LV systolic function and deterioration in the functional capacity and psychological aspects of the patients also in some cases adverse clinical outcomes such as heart failure, atrial fibrillation and death However, in daily clinical practice, not all patients with RV apical pacing will have these adverse events.

Patients' depression and anxiety before and after pacemaker implantation have been understudied. National and international literature show only few studies about anxiety and depression in patients who experience a pacemaker but more research has reported that these two variables are heavily noticed in cardiovascular patients.

In fact, they are so frequent in patients with coronary artery disease, heart failure, and in patients who had an implanted defibrillator. It has been suggested that anxiety and depression have a prevalence ranging from 18% to 50% in cardiac patients . The few studies that have studied anxiety and depression in pacemaker patients researched these variables only in an unfaithful time from the implantation and without considering any changes before and after the pacemaker implantation.

In elderly population on the consequent increase of patients with pacemakers, this problem becomes an essential one to study to support healthcare providers to know not only the problem, but also who is at high risk to develop anxiety and depression. Research has illustrated that lower levels of anxiety and depression among elderly patients are linked with perceptions of higher quality of life and less need for the use of health services. The improvement of wellbeing in elderly patients has implications for health care providers designing preoperative and follow up care for patients undergoing pacemaker Implantation.

Study Type

Observational

Enrollment (Actual)

182

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

  • Egypt
      • Kafr Ash Shaykh, Egypt
        • Kafrelsheikh University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from heart block and indicated for permanent cardiac pacemaker implantation

Description

Inclusion Criteria:

  • implantation of a dual-chamber pacemaker,
  • the ability to write and read the Arabic language,
  • adequate follow-up and
  • patients older than 18 years who were hospitalized for the first time for the implantation procedure

Exclusion Criteria:

  • Patients with history of psychiatric illness (mental, emotional, or behavioral disorders),
  • with a serious chronic disease,
  • with implantable cardioverter defibrillator or biventricular pacemaker and
  • patients who had not a stable programming of their device from the implantation.
  • patients less than 18 years old,
  • family and social environment problems prior and subsequent to PM implant,
  • financial problems

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead position and anxiety/ depression
Time Frame: one year
Assessment of the effect of the pacemaker lead position in the right ventricle on the psychological aspects of the patients in 1 year follow up period.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co morbidities and anxiety / depression
Time Frame: one year
Assessment the correlation between hypertension, diabetes , ischemia and variable pacemaker complications on the anxiety and depression of the patients in 1 year follow up period
one year

Collaborators and Investigators

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

Sponsor

Kafrelsheikh University

Investigators

  • Study Director: Reda Baiomy, PHD, Kafrelsheikh University

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)

August 1, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pacing on Anxiety/ Depression

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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