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Completed

NCT Number: NCT05344456

PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

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''.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Change in the device PVC algorithm to ''Off''

Device

PVC algorithm change from Atrial Pace mode to Off

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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