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Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker

NCT03843242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-05-31

No results posted yet for this study

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

Interventions

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.

DEVICE

Pacemaker with VpS® algorithm on

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.

DEVICE

Pacemaker with IRSplus algorithm on

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.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Keimyung University Dongsan Medical Center

    lead OTHER

Principal Investigators

  • Seongwook Han, M.D., Ph.D. · Keimyung University Dongsan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2021-06-24
Completion
2022-11-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843242 on ClinicalTrials.gov