Atrial TachycardiaNCT05344456
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
A study testing Change in the device PVC algorithm to ''Off'' in people with Atrial Tachycardia, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. In response certain Abbott (former St Jude Medical) pacemakers have a specific PVC response algorithm ''Atrial Pace''. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Tachycardia
- What is being tested?
- Change in the device PVC algorithm to ''Off''
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- 11 May 2022to 20 Aug 2023
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST Jude Medical or Abbott physiological ICD or CRT-D device
- PVC response setting ''Atrial Pace''
- Atrial tachycardia episode duration > 30s preceded by ventricular extrasystole and atrial pace in year 2020 or 2021
Who cannot join
- Permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study
- PVC response has been switched off before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Switching PVC Response ''Atrial Pace'' in ST JUDE Medical or Abbott ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) Devices to Off Mode Decreases the Burden of Atrial Tachycardia
Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. In response certain Abbott (former St Jude Medical) pacemakers have a specific PVC response algorithm ''Atrial Pace''. In this algorithm the PVARP (Post Ventricular Atrial Refractory Period) is extended to 480ms but the initial 150ms of the PVARP is deemed absolute. If atrial sensed event occurs after absolute PVARP the PVARP terminates and atrial pace follows after 330ms alert period. Two case reports exists where patients atrial tachycardia were suspected to be induced by this algorithm. In Helsinki University Hospital an index patient with multiple atrial tachycardia episodes was recognized in late 2020 where the cause of the tachycardias was suspected to be the PVC response algorithm ''Atrial Pace''. After programming the algorithm from Atrial Pace to off mode the patient had none atrial tachycardias during 2021. After investigating all the patients with physiological ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) device and analyzing remote monitoring transmissions from the year 2020 we found 25 patients with similar atrial tachycardia episodes possibly induced by the PVC response ''Atrial Pace''.
Read the detailed description
The device of the subjects participating to the study is interrogated and the PVC response algorithm is switched from ''Atrial Pace'' to ''Off'' mode.
Subjects are also requested to fulfill the EQ-5D-3L and ICD8 questionaries before the change in the device programming and after the 12 months surveillance.
- Conditions
- Atrial Tachycardia
- Being tested
- Change in the device PVC algorithm to ''Off''
- Keywords
- premature ventricular complex, pacemaker, arrythmia
- Medical subject headings
- Ventricular Premature Complexes, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in the device PVC algorithm to ''Off''Device
PVC algorithm change from Atrial Pace mode to Off
| Study group | Role | What they receive |
|---|---|---|
| PVC response ''Off'' | Experimental | Not described Receives: Device: Change in the device PVC algorithm to ''Off'' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay.
Atrial tachycardia episode is considered as an episode which duration is >30s and atrial rate > 180 beats per minute.
Measured: The number of these episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.
Number of any atrial tachycardia episodes and overall duration of atrial tachycardia episodes per participant.
Atrial tachycardia episode is considered as an episode which duration is >30s and atrial rate > 180 beats per minute.
Measured: The number of these episodes and overall duration of all atrial tachycardia episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.
Secondary outcomes (1)
Composite Change in the quality of life analyzed with EQ-5D-3L and ICD8 questionaries'.
In EQ-5D-3L questionary the quality of life is measured in scale from 0 to 100 and in ICD8 questionary in scale from 0 to 32. The overall score in both of the questionaries is compared at two time points.
Measured: baseline and after 12 months surveillance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start11 May 2022
- Primary completion1 Jun 2022
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial TachycardiaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Sane, Helsinki University Central Hospital
- Investigators
- Markus Sane, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344456
- Sponsor's protocol ID
- HUS/627/2022
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman DJ, Chasten T, Anderson K, Mullenix J, Rider K, Sun AY. Premature ventricular contraction response-induced new-onset atrial fibrillation. HeartRhythm Case Rep. 2018 Nov 30;5(3):120-123. doi: 10.1016/j.hrcr.2018.11.012. eCollection 2019 Mar. No abstract available.
PubMed 30891406Liu Y, Yuan X. Logic Analysis of Arrhythmia Triggered by Pacemaker Special Functions - An Educational Presentation. Braz J Cardiovasc Surg. 2021 Jun 1;36(3):412-415. doi: 10.21470/1678-9741-2020-0630.
PubMed 34387977
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching PVC Response ''Atrial Pace'' in ST JUDE Medical or Abbott ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) Devices to Off Mode Decreases the Burden of Atrial Tachycardia
- ClinicalTrials.gov ID
- NCT05344456
- Acronym / sponsor ID
- HUS/627/2022
- Conditions
- Atrial Tachycardia
- Keywords
- premature ventricular complex, pacemaker, arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 25 Apr 2022 (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.
Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. In response certain Abbott (former St Jude Medical) pacemakers have a specific PVC response algorithm ''Atrial Pace''. In this algorithm the PVARP (Post Ventricular Atrial Refractory Period) is extended to 480ms but the initial 150ms of the PVARP is deemed absolute. If atrial sensed event occurs after absolute PVARP the PVARP terminates and atrial pace follows after 330ms alert period. Two case reports exists where patients atrial tachycardia were suspected to be induced by this algorithm. In Helsinki University Hospital an index patient with multiple atrial tachycardia episodes was recognized in late 2020 where the cause of the tachycardias was suspected to be the PVC response algorithm ''Atrial Pace''. After programming the algorithm from Atrial Pace to off mode the patient had none atrial tachycardias during 2021. After investigating all the patients with physiological ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) device and analyzing remote monitoring transmissions from the year 2020 we found 25 patients with similar atrial tachycardia episodes possibly induced by the PVC response ''Atrial Pace''.
Detailed description
The device of the subjects participating to the study is interrogated and the PVC response algorithm is switched from ''Atrial Pace'' to ''Off'' mode.
Subjects are also requested to fulfill the EQ-5D-3L and ICD8 questionaries before the change in the device programming and after the 12 months surveillance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVC response ''Off'' | Experimental | Device: Change in the device PVC algorithm to ''Off'' |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ST Jude Medical or Abbott physiological ICD or CRT-D device
- PVC response setting ''Atrial Pace''
- Atrial tachycardia episode duration > 30s preceded by ventricular extrasystole and atrial pace in year 2020 or 2021
Key exclusion criteria (2 listed)
- Permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study
- PVC response has been switched off before enrollment
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 |
|---|---|---|
| Change in the device PVC algorithm to ''Off''PVC algorithm change from Atrial Pace mode to Off | Device | PVC response ''Off'' |
Primary outcome
Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay.
Time frame: The number of these episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.
Atrial tachycardia episode is considered as an episode which duration is >30s and atrial rate > 180 beats per minute.
Number of any atrial tachycardia episodes and overall duration of atrial tachycardia episodes per participant.
Time frame: The number of these episodes and overall duration of all atrial tachycardia episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.
Atrial tachycardia episode is considered as an episode which duration is >30s and atrial rate > 180 beats per minute.
1 secondary outcome
Composite Change in the quality of life analyzed with EQ-5D-3L and ICD8 questionaries'.
Time frame: baseline and after 12 months surveillance
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 28 Feb 2024.
- Background: PubMed 30891406Friedman DJ, Chasten T, Anderson K, Mullenix J, Rider K, Sun AY. Premature ventricular contraction response-induced new-onset atrial fibrillation. HeartRhythm Case Rep. 2018 Nov 30;5(3):120-123. doi: 10.1016/j.hrcr.2018.11.012. eCollection 2019 Mar. No abstract available.
- Background: PubMed 34387977Liu Y, Yuan X. Logic Analysis of Arrhythmia Triggered by Pacemaker Special Functions - An Educational Presentation. Braz J Cardiovasc Surg. 2021 Jun 1;36(3):412-415. doi: 10.21470/1678-9741-2020-0630.
- Individual participant dataSharing planned: No
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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.
Markus Sane principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in the device PVC algorithm to ''Off'' in people with Atrial Tachycardia, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 2 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay. (time frame: The number of these episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344456, which also lists 2 linked publications.
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 28 Feb 2024.