Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker

Heart Failure Clinical Trial

— LEADER  

Official title:

Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843242
• Other study ID #: 2018-08-022
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: November 23, 2022

Study information

• Verified date: May 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The recent study using IRSplus and VpS algorithm from Biotronik pacemaker showed the significant reduction in ventricular pacing to less than 3%.

The purpose of this study is to evaluate the efficacy of IRSplus and VpS algorithm in reducing ventricular pacing compared with conventional DDD pacing with a fixed AV delay.

Description:

The adverse cardiac outcomes due to right ventricular apical pacing with dual chamber pacemakers have been widely observed such as ventricular dyssynchrony resulting in reduced left ventricular function, increased risk of heart failure and atrial fibrillation. To minimize the ventricular pacing, manufacturers of pacemaker have made an effort to develop special algorithms designed to deliver right ventricular pacing only in case of demonstrated persistent long PR interval or repetitively lacking intrinsic ventricular activation.

Currently, there are three methods and algorithms are available with a pacemaker from the Biotronik SE & Co. KG to minimize right ventricular pacing as follows; DDD mode with fixed longer atrioventricular (AV) delay than intrinsic conduction time; Intrinsic rhythm support (IRSplus); Ventricular pacing suppression (VpS).

In the real world, it is the most common practice to program the DDD(R) mode with fixed long AV delay because of physician's concerns about the possible failure of an algorithm or long pause being resulted from 2 consecutive loss of AV conduction by the algorithm. However, the main disadvantage of a fixed with long AV delay is that the prolonged total atrial refractory period (TARP) results in changes of the upper rate behavior (i.e., pseudo-Wenckebach AV block and subsequently 2:1 block at lower atrial tracking rates). The possibility of pacemaker-mediated tachycardia is getting high if the post-ventricular atrial refractory period (PVARP) is shortened to compensate. Furthermore, there is a high chance to have fusion/pseudo-fusion of ventricular pacing in a fixed long AV delay because the AV conduction is dynamic according to the heart rate.

The recent systematic review showed that there are no significant differences between the pacing modes for mortality, heart failure, stroke, and atrial fibrillation (AF) in patients with sinus node dysfunction (SND) without AV block. However, the dual chamber pacemaker is still recommended in patients with SND due to lack of tools to identify patients at high risk of developing the complete AV block. The meta-analysis about the effect of the reduction in unnecessary ventricular pacing using a sophisticated algorithm in patients with SND showed there are no benefits in clinical outcomes compared with conventional DDD mode. But the percentage of ventricular pacing in ventricular pacing reduction modality group was not negligible between 1~11.5%. The result might be changed if we have data with a more significant reduction in ventricular pacing using difference algorithm. The recent study using IRSplus and VpS algorithm from Biotronik pacemaker showed the significant reduction in ventricular pacing to less than 3%.

The purpose of this study is to evaluate the efficacy of IRSplus and VpS algorithm compared with conventional DDD pacing with a fixed AV delay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 23, 2022
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Sick sinus syndrome

• No evidence of 2nd and 3rd degree AV block

• Provide written informed consent

• Age = 20 years old

Exclusion Criteria:

• 2nd and 3rd degree AV block

• History of AF

• patients with older version of pacemaker

• Life expectancy = one year

• Pregnant or lactating women

Related Conditions & MeSH terms

• Heart Failure
• Pacemaker
• Sick Sinus Syndrome

Intervention

Device:
• Pacemaker with Fixed long AV delay
Fixed AV delay was applied in the first 3 months of pacemaker implantation according to previously proposed definition.
• Pacemaker with VpS® algorithm on
After first 3 months of pacemaker implantation, the patients will be randomized into two groups (Vp-suppression algorithm on group vs. IRS-plus algorithm on group) using a centralized randomization system. In Vp-suppression algorhithm on group, Vp suppression algorithm of Enitra 8 DR-T pacemaker will be turned on at 3month visit after enrollment. The patient will be followed at 3-month after enrollment and at 6-month and 12-month after applying the specific algorithm.
• Pacemaker with IRSplus algorithm on
After first 3 months of pacemaker implantation, the patients will be randomized into two groups (Vp-suppression algorithm on group vs. IRS-plus algorithm on group) using a centralized randomization system. In IRS-plus algorithm on group, IRS plus algorithm of Enitra 8 DR-T pacemaker will be turned on at 3 month visit after enrollment. The patient will be followed at 3-month after enrollment and at 6-month and 12-month after applying the specific algorithm.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Fatima Hospital	Daegu
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital	Daegu
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital	Daegu
Korea, Republic of	Dongguk University Medical Center	Ilsan
Korea, Republic of	Pusan National University Hospital	Pusan

Sponsors (2)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Biotronik SE & Co. KG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of right ventricular pacing	the right ventricle pacing percentage appeared on the pacemaker interrogation	During first 3 months after the study enrollment
Primary	Percentage of right ventricular pacing	the right ventricle pacing percentage appeared on the pacemaker interrogation	During 4 ~ 9 months after the study enrollment
Primary	Percentage of right ventricular pacing	the right ventricle pacing percentage appeared on the pacemaker interrogation	During 10 ~ 15 months after the study enrollment
Secondary	New onset atrial fibrillation	Percentage of patients with new onset atrial fibrillation during the observation period	During 12 months after randomization (15 months after enrollment)
Secondary	Occurrence of heart failure	Percentage of patients who experienced symptomatic heart failure during the observation period	During 12 months after randomization (15 months after enrollment)
Secondary	Percentage of atrial high rate episode	Percentage of atrial high rate episode appeared on the pacemaker interrogation	During 12 months after randomization (15 months after enrollment)