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

Sponsor

Kafrelsheikh University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06008340

Collaborator

(none)

182

Enrollment

Location

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pacing-Induced Cardiomyopathy	Device: Dual chamber Pacemaker

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

182 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Outcome Measures

Primary Outcome Measures

Lead position and anxiety/ depression [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.

Secondary Outcome Measures

Co morbidities and anxiety / depression [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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