Clinical trial NCT03843242: Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker
Official title: Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sick Sinus Syndrome
Pacemaker
Heart Failure
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2019-02-18
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of right ventricular pacing
timeFrame: During first 3 months after the study enrollment
measure: Percentage of right ventricular pacing
timeFrame: During 4 ~ 9 months after the study enrollment
measure: Percentage of right ventricular pacing
timeFrame: During 10 ~ 15 months after the study enrollment
Secondary outcomes:
measure: New onset atrial fibrillation
timeFrame: During 12 months after randomization (15 months after enrollment)
measure: Occurrence of heart failure
timeFrame: During 12 months after randomization (15 months after enrollment)
measure: Percentage of atrial high rate episode
timeFrame: During 12 months after randomization (15 months after enrollment)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
city: Daegu
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Seongwook Han, M.D., Ph.D.
role: STUDY_CHAIR
References: