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

Pacing-Induced Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06008340
• Other study ID #: Pacing on Anxiety/ Depression
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: August 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: November 1, 2023
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Pacing-Induced Cardiomyopathy

Intervention

Device:
• Dual chamber Pacemaker
Anti bradycardia device implanted in patients with complete heart block, the device has 2 leads, one in the RT atrium and the other in RV. The RV lead positioned either apical or septal

Locations

Country	Name	City	State
Egypt	Kafrelsheikh university	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Chesney MA, Rosenman RH. Type A behavior: Observations on the past decade. Heart Lung. 1982 Jan-Feb;11(1):12-9. No abstract available. — View Citation

Polikandrioti M, Tzirogiannis K, Zyga S, Koutelekos I, Vasilopoulos G, Theofilou P, Panoutsopoulos G. Effect of anxiety and depression on the fatigue of patients with a permanent pacemaker. Arch Med Sci Atheroscler Dis. 2018 Feb 5;3:e8-e17. doi: 10.5114/amsad.2018.73231. eCollection 2018. — View Citation

Prinzen FW, Peschar M. Relation between the pacing induced sequence of activation and left ventricular pump function in animals. Pacing Clin Electrophysiol. 2002 Apr;25(4 Pt 1):484-98. doi: 10.1046/j.1460-9592.2002.00484.x. — View Citation

Tops LF, Schalij MJ, Holman ER, van Erven L, van der Wall EE, Bax JJ. Right ventricular pacing can induce ventricular dyssynchrony in patients with atrial fibrillation after atrioventricular node ablation. J Am Coll Cardiol. 2006 Oct 17;48(8):1642-8. doi: 10.1016/j.jacc.2006.05.072. Epub 2006 Sep 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead position and anxiety/ depression	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	Co morbidities and anxiety / depression	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