Sick Sinus SyndromeLEADERNCT03843242
Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker
A study testing Pacemaker with Fixed long AV delay, Pacemaker with VpS® algorithm on and Pacemaker with IRSplus algorithm on in people with Sick Sinus Syndrome and Pacemaker, run by Keimyung University Dongsan Medical Center at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sick Sinus Syndrome, Pacemaker, Heart Failure
- What is being tested?
- Pacemaker with Fixed long AV delay, Pacemaker with VpS® algorithm on and Pacemaker with IRSplus algorithm on
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 30 May 2019to 23 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sick sinus syndrome
- No evidence of 2nd and 3rd degree AV block
- Provide written informed consent
- Age ≥ 20 years old
Who cannot join
- 2nd and 3rd degree AV block
- History of AF
- patients with older version of pacemaker
- Life expectancy ≤ one year
- Pregnant or lactating women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Daegu Fatima Hospital
Daegu, 41199
Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
Daegu, 41944
Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
Daegu, 42415
Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center
Daegu, 42472
Dongguk University Medical Center
Ilsan
Pusan National University Hospital
Pusan, 49241
About this study
Official title: Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber
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.
Read the 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.
- Conditions
- Sick Sinus Syndrome, Pacemaker, Heart Failure
- Being tested
- Pacemaker with Fixed long AV delay, Pacemaker with VpS® algorithm on, Pacemaker with IRSplus algorithm on
- Medical subject headings
- Sick Sinus Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker with Fixed long AV delayDevice
Fixed AV delay was applied in the first 3 months of pacemaker implantation according to previously proposed definition.
Pacemaker with VpS® algorithm onDevice
- 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 onDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Device: Pacemaker with Fixed long AV delay; Device: Pacemaker with IRSplus algorithm on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of right ventricular pacing
the right ventricle pacing percentage appeared on the pacemaker interrogation
Measured: During first 3 months after the study enrollment
Percentage of right ventricular pacing
the right ventricle pacing percentage appeared on the pacemaker interrogation
Measured: During 4 ~ 9 months after the study enrollment
Percentage of right ventricular pacing
the right ventricle pacing percentage appeared on the pacemaker interrogation
Measured: During 10 ~ 15 months after the study enrollment
Secondary outcomes (3)
New onset atrial fibrillation
Percentage of patients with new onset atrial fibrillation during the observation period
Measured: During 12 months after randomization (15 months after enrollment)
Occurrence of heart failure
Percentage of patients who experienced symptomatic heart failure during the observation period
Measured: During 12 months after randomization (15 months after enrollment)
Percentage of atrial high rate episode
Percentage of atrial high rate episode appeared on the pacemaker interrogation
Measured: During 12 months after randomization (15 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start30 May 2019
- Primary completion24 Jun 2021
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Principal investigator, Seongwook Han, Keimyung University Dongsan Medical Center
- Investigators
- Seongwook Han, M.D., Ph.D., Study chair, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843242
- Sponsor's protocol ID
- 2018-08-022
- Acronym
- LEADER
- Status last verified
- May 2023
- First submitted
- 11 Feb 2019
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber
- ClinicalTrials.gov ID
- NCT03843242
- Acronym / sponsor ID
- LEADER / 2018-08-022
- Conditions
- Sick Sinus Syndrome, Pacemaker, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 30 May 2019 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pacemaker with Fixed long AV delay | Experimental | Device: Pacemaker with Fixed long AV delay1. 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 |
| Pacemaker with VpS® algorithm on | Experimental | Device: Pacemaker with Fixed long AV delay, Device: Pacemaker with VpS® algorithm onVp 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. |
| Pacemaker with IRSplus algorithm on | Experimental | Device: Pacemaker with Fixed long AV delay, Device: Pacemaker with IRSplus algorithm onIRS 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sick sinus syndrome
- No evidence of 2nd and 3rd degree AV block
- Provide written informed consent
- Age ≥ 20 years old
Key exclusion criteria (5 listed)
- 2nd and 3rd degree AV block
- History of AF
- patients with older version of pacemaker
- Life expectancy ≤ one year
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker with Fixed long AV delayFixed AV delay was applied in the first 3 months of pacemaker implantation according to previously proposed definition. | Device | Pacemaker with Fixed long AV delay, Pacemaker with IRSplus algorithm on, Pacemaker with VpS® algorithm on |
| Pacemaker with VpS® algorithm on1. 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 VpS® algorithm on |
| Pacemaker with IRSplus algorithm on1. 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. | Device | Pacemaker with IRSplus algorithm on |
Primary outcome
Percentage of right ventricular pacing
Time frame: During first 3 months after the study enrollment
the right ventricle pacing percentage appeared on the pacemaker interrogation
Percentage of right ventricular pacing
Time frame: During 4 ~ 9 months after the study enrollment
the right ventricle pacing percentage appeared on the pacemaker interrogation
Percentage of right ventricular pacing
Time frame: During 10 ~ 15 months after the study enrollment
the right ventricle pacing percentage appeared on the pacemaker interrogation
3 secondary outcomes
New onset atrial fibrillation
Time frame: During 12 months after randomization (15 months after enrollment)
Occurrence of heart failure
Time frame: During 12 months after randomization (15 months after enrollment)
Percentage of atrial high rate episode
Time frame: During 12 months after randomization (15 months after enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seongwook Han, M.D., Ph.D. study chair
Keimyung University Dongsan Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker with Fixed long AV delay, Pacemaker with VpS® algorithm on and Pacemaker with IRSplus algorithm on in people with Sick Sinus Syndrome and Pacemaker, run by Keimyung University Dongsan Medical Center at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of right ventricular pacing (time frame: During first 3 months after the study enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.