PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05344456
Collaborator
(none)
21
1
1
13.7
1.5

Study Details

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''.

Condition or Disease Intervention/Treatment Phase
  • Device: Change in the device PVC algorithm to ''Off''
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 11, 2022
Actual Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PVC response ''Off''

Device: Change in the device PVC algorithm to ''Off''
PVC algorithm change from Atrial Pace mode to Off

Outcome Measures

Primary Outcome Measures

  1. Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay. [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. [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Central Hospital Helsinki Finland

Sponsors and Collaborators

  • Helsinki University Central Hospital

Investigators

  • Principal Investigator: Markus Sane, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Markus Sane, M.D, PhD, Cardiologist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT05344456
Other Study ID Numbers:
  • HUS/627/2022
First Posted:
Apr 25, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Markus Sane, M.D, PhD, Cardiologist, Helsinki University Central Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022