Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06045143
Other study ID # LV strain in pacemaker's
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 1, 2024

Study information

Verified date September 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.


Description:

Permanent cardiac pacing is the most efficient treatment for various conduction disorders, including high-degree atrioventricular block and symptomatic sick sinus syndrome. High-burden right ventricular (RV) pacing is often tolerated for decades without overt left ventricular (LV) failure in most patients. It has been shown, however, that prolonged RV pacing reduces LV function and ultimately causes heart failure. Left ventricular ejection fraction (LVEF) may decrease in specific individuals with pacemaker implants following pacing, which is called Pacing-induced cardiomyopathy (PICM). However, pacing-induced LV dysfunction (PIVD) at milder severity levels has also been documented.RV apical pacing, the classic site for pacemaker lead implantation, results in ventricular dys-synchrony and deterioration of left ventricular (LV) function and ejection fraction, like left bundle branch block. Recently, alternative sites are arising, such as right ventricular outflow tract (RVOT) and the septum. Studies show that deformation imaging by speckle tracking echocardiography following pacemaker implantation can predict the patients at higher risk for PCIM and PIVD at long-term follow-up. Deformation imaging, or strain imaging, provides unique Information on regional and global ventricular function. Global longitudinal strain is Known to be more precise than ejection Fraction. It is now used in patients with heart failure, ischemic heart disease, and Receiving chemotherapy to detect early Changes in cardiac function before changes in ejection fraction. Speckle tracking Echocardiography for strain measurement Depends on tracking of speckles throughout the Cardiac cycle in apical 4,3, and 2 chamber Views. The software allows the elaboration of myocardial deformation in 3 spatial directions: Longitudinal, radial, and circumferential. Predicting PICM and PIVD 6 months after pacemaker implantation is possible by measuring global longitudinal strain (GLS) baseline one and six months after implantation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date December 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Any patients older than 18 years with conduction disturbances necessitating pacemaker implantation and 2. who had preserved LVEF (=50%) were presented to Assuit University Heart Center. Exclusion Criteria: 1. Patients with impaired systolic function (LVEF <50%). 2. Ischemic heart disease. 3. Significant valvular heart disease (moderate to severe). 4. Pregnancy. 5. Poor echogenic window. 6. Patient refusal.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Patients undergoing DDD pacemaker implantation
compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Right ventricular apical versus septal pacing Echocardiographic study. This study aims to compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography. 1year
See also
  Status Clinical Trial Phase
Recruiting NCT05015660 - Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing N/A
Completed NCT04323670 - Master Study Investigating the Guiding Catheter Selectra 3D N/A
Recruiting NCT02931760 - Placement Of Cardiac PacemaKer Trial (POCKET)-RCT N/A
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A
Completed NCT04163965 - Data Collection for Pacemaker Recognition Through Capacitive ECG N/A
Not yet recruiting NCT06377046 - Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial N/A
Completed NCT06068699 - Postcards to Improve Remote Monitoring Adherence Among Veterans N/A
Completed NCT04269733 - Risk of Pacing-induced Cardiomyopathy
Recruiting NCT05868616 - Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Recruiting NCT06371846 - Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices
Recruiting NCT03357926 - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Recruiting NCT05884359 - Left Bundle Branch Area Mapping for Conduction System Pacing
Completed NCT04372654 - Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients N/A
Not yet recruiting NCT05695534 - Use of VR in Patients' Education Prior to Implantation of PPM N/A
Completed NCT04067024 - Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker N/A
Recruiting NCT06318130 - Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes N/A
Recruiting NCT04416958 - Pacing to Maintain Physiologic Ventricular Activation
Completed NCT05222672 - Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem
Enrolling by invitation NCT04383392 - QoL Between CIEDs With and Without Rate Adaptive Pacing N/A
Completed NCT04957771 - Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation N/A

External Links