PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

NCT ID: NCT05344456

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2023-08-20

Brief Summary

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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

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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

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Atrial Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVC response ''Off''

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

PVC algorithm change from Atrial Pace mode to Off

Interventions

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

PVC algorithm change from Atrial Pace mode to Off

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Markus Sane

M.D, PhD, Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Sane

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 30891406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34387977 (View on PubMed)

Other Identifiers

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HUS/627/2022

Identifier Type: -

Identifier Source: org_study_id

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