Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker

NCT03843242 | Completed DMC

• 1 other identifier: 2018-08-022
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 6

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.

Conditions

Sick Sinus Syndrome; Pacemaker; Heart Failure

Outcome Measures

Primary Outcomes (3)

• Percentage of right ventricular pacing

  the right ventricle pacing percentage appeared on the pacemaker interrogation

  During first 3 months after the study enrollment

• Percentage of right ventricular pacing

  the right ventricle pacing percentage appeared on the pacemaker interrogation

  During 4 ~ 9 months after the study enrollment

• Percentage of right ventricular pacing

  the right ventricle pacing percentage appeared on the pacemaker interrogation

  During 10 ~ 15 months after the study enrollment

Secondary Outcomes (3)

• New onset atrial fibrillation

  During 12 months after randomization (15 months after enrollment)

• Occurrence of heart failure

  During 12 months after randomization (15 months after enrollment)

• Percentage of atrial high rate episode

  During 12 months after randomization (15 months after enrollment)

Study Arms (3)

Pacemaker with Fixed long AV delay

EXPERIMENTAL

1. Patients who meet the inclusion criteria and is implanted with a Biotronik Enitra 8 DR-T pacemaker are eligible. 2. The pacemaker was programmed with a long and fixed atrioventricular interval for the first 3 months. 3. 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

Device: Pacemaker with Fixed long AV delay

Pacemaker with VpS® algorithm on

EXPERIMENTAL

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.

Device: Pacemaker with Fixed long AV delay; Device: Pacemaker with VpS® algorithm on

Pacemaker with IRSplus algorithm on

EXPERIMENTAL

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.

Device: Pacemaker with Fixed long AV delay; Device: Pacemaker with IRSplus algorithm on

Interventions

Pacemaker with Fixed long AV delay DEVICE

Fixed AV delay was applied in the first 3 months of pacemaker implantation according to previously proposed definition.

Pacemaker with Fixed long AV delay; Pacemaker with IRSplus algorithm on; Pacemaker with VpS® algorithm on

Pacemaker with VpS® algorithm on DEVICE

1. 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. 2. In Vp-suppression algorhithm on group, Vp suppression algorithm of Enitra 8 DR-T pacemaker will be turned on at 3month visit after enrollment. 3. The patient will be followed at 3-month after enrollment and at 6-month and 12-month after applying the specific algorithm.

Pacemaker with VpS® algorithm on

Pacemaker with IRSplus algorithm on DEVICE

1. 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. 2. 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. 3. 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sick sinus syndrome
• No evidence of 2nd and 3rd degree AV block
• Provide written informed consent
• Age ≥ 20 years old

You may not qualify if:

• nd and 3rd degree AV block
• History of AF
• patients with older version of pacemaker
• Life expectancy ≤ one year
• Pregnant or lactating women

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (6)

Daegu Fatima Hospital

Daegu, 41199, South Korea

Location

Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Dongguk University Medical Center

Ilsan, South Korea

Location

Pusan National University Hospital

Pusan, 49241, South Korea

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seongwook Han, M.D., Ph.D.

  Keimyung University Dongsan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 18, 2019
• Study Start: May 30, 2019
• Primary Completion: June 24, 2021
• Study Completion: November 23, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

KR (6)