NCT04858672

Brief Summary

Shock testing during ICD generator replacement has been omitted by many centers. A previous study revealed lead failures in internally cardioverted patients with previously normal HV-lead values. The real prevalence of unrecognized "silent" lead failure in ICD patients remains unknown. As a consequence, patients may be equipped with an ICD which is unable to provide life-saving shocks. The proposed registry aims to include patients presenting for ICD generator replacement or electrical cardioversion of atrial arrhythmia. The protocol mandates either a commanded synchronized high energy shock prior to generator replacement or internal cardioversion of atrial arrhythmia to provoke the unmasking of silent lead failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

3.2 years

First QC Date

April 10, 2021

Last Update Submit

June 1, 2022

Conditions

Implantable Defibrillator Lead DysfunctionImplantable Automatic Defibrillator MalfunctionImplantable Defibrillator User

Keywords

Implantable Cardioverter Defibrillator Lead DysfunctionSilent Lead FailureImplantable Cardioverter Defibrillator Malfunction

Outcome Measures

Primary Outcomes (1)

  • Lead failure after HV shock

    Any single or combination of the following observations: * HV impedance \>20 Ohm * Pacing impedance \>2000 Ohm * Pacing threshold \>5V/0,4ms * Pacing threshold increase by factor 2 or more * Pacing exit block * Sensing \< 4mV * Relative decrease in sensing by 50% or more * Detection of lead noise or artifacts on the RV pace-sense or shock channel * Any lead associated error reports by the ICD preventing delivery of the ICD shock

    3 hours within testing

Secondary Outcomes (3)

  • Changes in Device Function not leading to primary outcome

    3 hours within testing

  • Adverse events within shock testing

    3 hours within testing

  • Rhythm after synchronized shock

    3 hours within testing

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We aim to include ICD patients presenting for generator exchange or cardioversion for atrial arrhythmia in a multicenter registry. We address an unselected cohort of ICD patients (single chamber ICD, dual chamber ICD, CRT-D). All generator and lead manufacturers will be included. To avoid a manufacturer bias, an upper limit of patients per manufacturer is imposed at 100 leads/patients per manufacturer. Patients who received adequate and successful ICD shock therapy within the past 12 months will be excluded, as they have a very low likelihood of defective RV lead prevalence. Also patients with parameters indicating lead failure during device control and patients with contraindications for high voltage shocks (e.g. thrombus) will be excluded.

You may qualify if:

  • Age ≥ 18 years
  • Informed, written consent
  • Status post ICD implantation, including CRT-D
  • Battery in EOL, ERM or ERI, ERT with indication for elective ICD generator replacement or patients presenting for electrical cardioversion for atrial arrhythmia.

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Patients under guardianship or with mental disorders/disabilities
  • Recent adequate and successful ICD shock therapy (within the past 12 months)
  • Patients in the cardioversion arm with low battery (\<1 year to ERI/RRT)
  • Patients with intracardiac thrombus
  • Participation in any other investigational study that may interfere with interpretation of the study and registry results
  • Indications of an already compromised RV lead (Pacing impedance \<200 or \>2000 Ohm, Pacing threshold \>5V/0.4ms, RV Sensing \<4mV, HV impedance \>80, presence of lead noise)
  • Systems with recalled leads or leads known to have an elevated failure risk: Riata™ and Riata ST™ (St. Jude Medical, St. Paul, Minnesota, USA), Sprint Fidelis™ (Medtronic, Minneapolis, Minnesota, USA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of electrophysiology, Heart Center Cologne, University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Related Publications (10)

  • Swerdlow CD, Porterfield JE, Kottam AG, Kroll MW. Why low-voltage shock impedance measurements fail to reliably detect insulation breaches in transvenous defibrillation leads. Heart Rhythm. 2019 Nov;16(11):1729-1737. doi: 10.1016/j.hrthm.2019.05.021. Epub 2019 May 21.

    PMID: 31125671BACKGROUND

  • Phan K, Kabunga P, Kilborn MJ, Sy RW. Defibrillator Threshold Testing at Generator Replacement: Is it Time to Abandon the Practice? Pacing Clin Electrophysiol. 2015 Jul;38(7):777-81. doi: 10.1111/pace.12630. Epub 2015 Apr 20. No abstract available.

    PMID: 25790073BACKGROUND

  • Wilkoff BL, Fauchier L, Stiles MK, Morillo CA, Al-Khatib SM, Almendral J, Aguinaga L, Berger RD, Cuesta A, Daubert JP, Dubner S, Ellenbogen KA, Mark Estes NA 3rd, Fenelon G, Garcia FC, Gasparini M, Haines DE, Healey JS, Hurtwitz JL, Keegan R, Kolb C, Kuck KH, Marinskis G, Martinelli M, McGuire M, Molina LG, Okumura K, Proclemer A, Russo AM, Singh JP, Swerdlow CD, Teo WS, Uribe W, Viskin S, Wang CC, Zhang S. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. Heart Rhythm. 2016 Feb;13(2):e50-86. doi: 10.1016/j.hrthm.2015.11.018. Epub 2015 Dec 1. No abstract available.

    PMID: 26607062BACKGROUND

  • Luker J, Kuhr K, Sultan A, Nolker G, Omran H, Willems S, Andrie R, Schrickel JW, Winter S, Vollmann D, Tilz RR, Jobs A, Heeger CH, Metzner A, Meyer S, Mischke K, Napp A, Fahrig A, Steinhauser S, Brachmann J, Baldus S, Mahajan R, Sanders P, Steven D. Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial. Circulation. 2019 Sep 24;140(13):1061-1069. doi: 10.1161/CIRCULATIONAHA.119.041320. Epub 2019 Aug 30.

    PMID: 31466479BACKGROUND

  • Russo AM, Chung MK. Is defibrillation testing necessary? Cardiol Clin. 2014 May;32(2):211-24. doi: 10.1016/j.ccl.2014.01.003.

    PMID: 24793798BACKGROUND

  • Goyal R, Harvey M, Horwood L, Bogun F, Castellani M, Chan KK, Daoud E, Niebauer M, Man KC, Morady F, Strickberger SA. Incidence of lead system malfunction detected during implantable defibrillator generator replacement. Pacing Clin Electrophysiol. 1996 Aug;19(8):1143-6. doi: 10.1111/j.1540-8159.1996.tb04183.x.

    PMID: 8865211BACKGROUND

  • Swerdlow CD, Koneru JN, Gunderson B, Kroll MW, Ploux S, Ellenbogen KA. Impedance in the Diagnosis of Lead Malfunction. Circ Arrhythm Electrophysiol. 2020 Feb;13(2):e008092. doi: 10.1161/CIRCEP.119.008092. Epub 2020 Jan 27.

    PMID: 31985260BACKGROUND

  • Bun SS, Duytschaever M, Tavernier R. Defibrillation testing can reveal 'concealed' lead fracture. Europace. 2013 Jan;15(1):54. doi: 10.1093/europace/eus173. Epub 2012 Jun 19. No abstract available.

    PMID: 22719061BACKGROUND

  • Parwani AS, Lacour P, Franke P, Reichert U, Christoph K, Beiert T, Supryn R, Rangasamy K, Kull T, Hohendanner F, Heinzel F, Kucher A, Boldt LH, Pieske B, Blaschke F. Low-voltage shock impedance measurements: A false sense of security. Pacing Clin Electrophysiol. 2021 Jan;44(1):93-100. doi: 10.1111/pace.14117. Epub 2020 Nov 19.

    PMID: 33140439BACKGROUND

  • Shah P, Singh G, Chandra S, Schuger CD. Failure to deliver therapy by a Riata Lead with internal wire externalization and normal electrical parameters during routine interrogation. J Cardiovasc Electrophysiol. 2013 Jan;24(1):94-6. doi: 10.1111/j.1540-8167.2012.02361.x. Epub 2012 May 21.

    PMID: 22612668BACKGROUND

Study Officials

  • Daniel Steven, Prof.

    University of Cologne, Heart Center, Dept. of Electrophysiology

    PRINCIPAL INVESTIGATOR

  • Jakob Lüker, Dr.

    University of Cologne, Heart Center, Dept. of Electrophysiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Wörmann, MD

CONTACT

+4917699992357jonas.woermann@uk-koeln.de

Jakob Lüker, MD

CONTACT

+4922147832396jakob.lueker@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 26, 2021

Study Start

March 23, 2022

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

June 2, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)