PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
February 24, 2024 updated by: Markus Sane, Helsinki University Central Hospital
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''.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Helsinki, Finland
- Helsinki University Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study
- PVC response has been switched off before enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PVC response ''Off''
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PVC algorithm change from Atrial Pace mode to Off
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Change in the quality of life analyzed with EQ-5D-3L and ICD8 questionaries'.
Time Frame: baseline and after 12 months surveillance
|
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.
|
baseline and after 12 months surveillance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Markus Sane, Helsinki University Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Liu 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
August 20, 2023
Study Registration Dates
First Submitted
April 14, 2022
First Submitted That Met QC Criteria
April 22, 2022
First Posted (Actual)
April 25, 2022
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 24, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/627/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.