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Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits

8. mars 2022 oppdatert av: Margaret Infeld, University of Vermont

Electrically Guided Bachmann's Bundle Pacing Pilot Study: A Novel Lead Placement Strategy With Potential Antiarrhythmic Benefits

Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • University of Vermont Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subject is >18 years old
  • Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
  • Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)
  • Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires

Exclusion Criteria:

  • Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
  • Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
  • Subject has resting spontaneous sinus rate >85 beats-per-minute
  • Subject has left ventricular ejection fraction <45%
  • Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
  • Subject is currently enrolled in a potentially confounding trial
  • Subject is pregnant
  • Subject's anticipated life expectancy is less than 1 year

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Bachmann's bundle area pacing
Lead placement in Bachmann's bundle area
Fremgangsmåte: Bachmann's bundle lead placement
Atrial lead placement at Bachmann's bundle area
Aktiv komparator: Right atrial appendage pacing
Lead placement in the right atrial appendage
Fremgangsmåte: Right atrial appendage lead placement
Atrial lead placement in the right atrial appendage

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Atrial arrhythmia burden from pacemaker counters
Tidsramme: Over 15 month follow up
Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.
Over 15 month follow up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups
Tidsramme: At implant
At implant
Atrial lead procedure time
Tidsramme: At implant
At implant
Atrial lead fluoroscopy time
Tidsramme: At implant
At implant
Atrial lead complications
Tidsramme: Over 15 month follow up
Over 15 month follow up
Atrial lead capture threshold (Volts)
Tidsramme: Over 15 month follow up
Over 15 month follow up
Atrial lead sensing threshold (millivolts)
Tidsramme: Over 15 month follow up
Over 15 month follow up
Atrial lead impedance threshold (Ohms)
Tidsramme: Over 15 month follow up
Over 15 month follow up
Atrial Fibrillation Severity Scale Version 2.0
Tidsramme: Over 15 month follow up

Change in quality of life. The Atrial Fibrillation Severity Scale (AFSS) is composed of 19 items investigating four domains:

  1. AF burden (comprised of AF frequency + AF duration + AF severity): score range is 3-10, higher score = greater burden
  2. Health care utilization: score range is 0-7 for each question, higher score = more utilization
  3. Symptoms: score range is 0-35, higher score = greater symptom severity
  4. Global well-being: score range is 1-10, higher score = better quality of life
Over 15 month follow up
EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)
Tidsramme: Over 15 month follow up
Change in quality of life. The EQ-5D-3L is a standardized instrument to assess generic health-related quality of life and contains questions on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of the five dimension, respondents are offered three response categories (no problems, some problems, extreme problems), leading to 243 possible health states. These health states are then converted into index based values (utilities) ranging from 0 to 1 by applying a valuation algorithm. The EQ-5D instrument includes a visual analogue scale (VAS), on which the patient is asked to score his/her current health state between 0 (worst imaginable health state) and 100 (best imaginable health state).
Over 15 month follow up
Hospitalization or urgent outpatient visit for atrial fibrillation
Tidsramme: Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
Hospitalization or urgent outpatient visit for heart failure
Tidsramme: Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
Cerebrovascular accident
Tidsramme: Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
Atrial Fibrillation Ablation
Tidsramme: Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
New start or up-titration of medications for the primary diagnosis of atrial fibrillation
Tidsramme: Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Vermont

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mai 2021

Primær fullføring (Forventet)

1. juni 2023

Studiet fullført (Forventet)

1. juni 2023

Datoer for studieregistrering

Først innsendt

15. november 2021

Først innsendt som oppfylte QC-kriteriene

27. november 2021

Først lagt ut (Faktiske)

10. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 00001532

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

IPD-planbeskrivelse

De-identified data upon reasonable request

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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