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PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

H

Helsinki University Central Hospital (HUCH)

Status

Completed

Conditions

Atrial Tachycardia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05344456
HUS/627/2022

Details and patient eligibility

About

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''.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

PVC response ''Off''
Experimental group
Treatment:
Device: Change in the device PVC algorithm to ''Off''

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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