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PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

Primary Purpose

Atrial Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Change in the device PVC algorithm to ''Off''
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Tachycardia focused on measuring premature ventricular complex, pacemaker, arrythmia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PVC response ''Off''

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Composite Change in the quality of life analyzed with EQ-5D-3L and ICD8 questionaries'.
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.

Full Information

First Posted
April 14, 2022
Last Updated
August 23, 2023
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05344456
Brief Title
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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''.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Tachycardia
Keywords
premature ventricular complex, pacemaker, arrythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVC response ''Off''
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Change in the device PVC algorithm to ''Off''
Intervention Description
PVC algorithm change from Atrial Pace mode to Off
Primary Outcome Measure Information:
Title
Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay.
Description
Atrial tachycardia episode is considered as an episode which duration is >30s and atrial rate > 180 beats per minute.
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.
Title
Number of any atrial tachycardia episodes and overall duration of atrial tachycardia episodes per participant.
Description
Atrial tachycardia episode is considered as an episode which duration is >30s and atrial rate > 180 beats per minute.
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.
Secondary Outcome Measure Information:
Title
Composite Change in the quality of life analyzed with EQ-5D-3L and ICD8 questionaries'.
Description
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.
Time Frame
baseline and after 12 months surveillance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Sane
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30891406
Citation
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.
Results Reference
background
PubMed Identifier
34387977
Citation
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.
Results Reference
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PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

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