search
Back to results

Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker (LEADER)

Primary Purpose

Sick Sinus Syndrome, Pacemaker, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pacemaker with Fixed long AV delay
Pacemaker with VpS® algorithm on
Pacemaker with IRSplus algorithm on
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sick Sinus Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daegu Fatima Hospital
  • Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
  • Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
  • Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center
  • Dongguk University Medical Center
  • Pusan National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Pacemaker with Fixed long AV delay

Pacemaker with VpS® algorithm on

Pacemaker with IRSplus algorithm on

Arm Description

Patients who meet the inclusion criteria and is implanted with a Biotronik Enitra 8 DR-T pacemaker are eligible. The pacemaker was programmed with a long and fixed atrioventricular interval for the first 3 months. Definition of fixed AV delay (than intrinsic AV conduction) • If P-wave exists: intrinsic AV conduction time = As ~ Vs interval in the marker channel sensed AV delay = intrinsic AV conduction time + 20 msec paced AV delay = sensed AV delay + 30 msec • If no P-wave exits: intrinsic AV conduction time = Ap ~ Vs interval in the marker channel paced AV delay = intrinsic AV conduction time + 20 msec sensed AV delay = paced AV delay - 30 msec • If the intrinsic AV conduction time is ≥ 300ms, make paced/sensed AV delay 350/320 msec

Vp Suppression ON algorithm: This feature promotes the intrinsic AV conduction by only pacing the ventricle when intrinsic conduction becomes unstable or disappears. Depending on the presence or absence of AV conduction, the feature is implemented either in the ventricular pacing suppression state ADI(R), which promotes the intrinsic conduction, or in the DDD(R) ventricular pacing state Vp DDD(R), which provides ventricular pacing. Automatic switching capabilities between those two states promotethe intrinsic conduction as much as possible without harming the patient. Scheduled Vs searching tests look for intrinsic conduction using an extended AV delay of 450ms.

IRS plus algorithm: This algorithm incorporates two different functions: the first is scan hysteresis, which better enables the heart to pace on its own by periodically extending the search time for its natural pacing stimulus (the intrinsic AV conduction) over six consecutive atrial cycles. The second is the repetitive hysteresis, which recognizes when the heart is not pacing on its own (a consistent loss of intrinsic AV conduction lasting for six consecutive atrial cycles) and switches the mode of the device from extended to basic atrioventricular (AV) delay.

Outcomes

Primary Outcome Measures

Percentage of right ventricular pacing
the right ventricle pacing percentage appeared on the pacemaker interrogation
Percentage of right ventricular pacing
the right ventricle pacing percentage appeared on the pacemaker interrogation
Percentage of right ventricular pacing
the right ventricle pacing percentage appeared on the pacemaker interrogation

Secondary Outcome Measures

New onset atrial fibrillation
Percentage of patients with new onset atrial fibrillation during the observation period
Occurrence of heart failure
Percentage of patients who experienced symptomatic heart failure during the observation period
Percentage of atrial high rate episode
Percentage of atrial high rate episode appeared on the pacemaker interrogation

Full Information

First Posted
February 11, 2019
Last Updated
May 27, 2023
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Biotronik SE & Co. KG
search

1. Study Identification

Unique Protocol Identification Number
NCT03843242
Brief Title
Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker
Acronym
LEADER
Official Title
Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, Pacemaker, Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pacemaker with Fixed long AV delay
Arm Type
Experimental
Arm Description
Patients who meet the inclusion criteria and is implanted with a Biotronik Enitra 8 DR-T pacemaker are eligible. The pacemaker was programmed with a long and fixed atrioventricular interval for the first 3 months. Definition of fixed AV delay (than intrinsic AV conduction) • If P-wave exists: intrinsic AV conduction time = As ~ Vs interval in the marker channel sensed AV delay = intrinsic AV conduction time + 20 msec paced AV delay = sensed AV delay + 30 msec • If no P-wave exits: intrinsic AV conduction time = Ap ~ Vs interval in the marker channel paced AV delay = intrinsic AV conduction time + 20 msec sensed AV delay = paced AV delay - 30 msec • If the intrinsic AV conduction time is ≥ 300ms, make paced/sensed AV delay 350/320 msec
Arm Title
Pacemaker with VpS® algorithm on
Arm Type
Experimental
Arm Description
Vp Suppression ON algorithm: This feature promotes the intrinsic AV conduction by only pacing the ventricle when intrinsic conduction becomes unstable or disappears. Depending on the presence or absence of AV conduction, the feature is implemented either in the ventricular pacing suppression state ADI(R), which promotes the intrinsic conduction, or in the DDD(R) ventricular pacing state Vp DDD(R), which provides ventricular pacing. Automatic switching capabilities between those two states promotethe intrinsic conduction as much as possible without harming the patient. Scheduled Vs searching tests look for intrinsic conduction using an extended AV delay of 450ms.
Arm Title
Pacemaker with IRSplus algorithm on
Arm Type
Experimental
Arm Description
IRS plus algorithm: This algorithm incorporates two different functions: the first is scan hysteresis, which better enables the heart to pace on its own by periodically extending the search time for its natural pacing stimulus (the intrinsic AV conduction) over six consecutive atrial cycles. The second is the repetitive hysteresis, which recognizes when the heart is not pacing on its own (a consistent loss of intrinsic AV conduction lasting for six consecutive atrial cycles) and switches the mode of the device from extended to basic atrioventricular (AV) delay.
Intervention Type
Device
Intervention Name(s)
Pacemaker with Fixed long AV delay
Intervention Description
Fixed AV delay was applied in the first 3 months of pacemaker implantation according to previously proposed definition.
Intervention Type
Device
Intervention Name(s)
Pacemaker with VpS® algorithm on
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pacemaker with IRSplus algorithm on
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of right ventricular pacing
Description
the right ventricle pacing percentage appeared on the pacemaker interrogation
Time Frame
During first 3 months after the study enrollment
Title
Percentage of right ventricular pacing
Description
the right ventricle pacing percentage appeared on the pacemaker interrogation
Time Frame
During 4 ~ 9 months after the study enrollment
Title
Percentage of right ventricular pacing
Description
the right ventricle pacing percentage appeared on the pacemaker interrogation
Time Frame
During 10 ~ 15 months after the study enrollment
Secondary Outcome Measure Information:
Title
New onset atrial fibrillation
Description
Percentage of patients with new onset atrial fibrillation during the observation period
Time Frame
During 12 months after randomization (15 months after enrollment)
Title
Occurrence of heart failure
Description
Percentage of patients who experienced symptomatic heart failure during the observation period
Time Frame
During 12 months after randomization (15 months after enrollment)
Title
Percentage of atrial high rate episode
Description
Percentage of atrial high rate episode appeared on the pacemaker interrogation
Time Frame
During 12 months after randomization (15 months after enrollment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seongwook Han, M.D., Ph.D.
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Daegu Fatima Hospital
City
Daegu
ZIP/Postal Code
41199
Country
Korea, Republic of
Facility Name
Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Dongguk University Medical Center
City
Ilsan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
49241
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker

We'll reach out to this number within 24 hrs