PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

NCT05344456 | Completed

• 1 other identifier: HUS/627/2022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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''. 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''.

Conditions

Atrial Tachycardia

Keywords

premature ventricular complex; pacemaker; arrythmia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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'.

  baseline and after 12 months surveillance

Study Arms (1)

PVC response ''Off''

EXPERIMENTAL

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

Interventions

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

PVC algorithm change from Atrial Pace mode to Off

PVC response ''Off''

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study
• PVC response has been switched off before enrollment

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Finland

Location

Related Publications (2)

• 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.

  PMID: 30891406 BACKGROUND

• 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.

  PMID: 34387977 BACKGROUND

MeSH Terms

Conditions

Ventricular Premature Complexes; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Sane

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD, Cardiologist

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 25, 2022
• Study Start: May 11, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 20, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)