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

8. marts 2022 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • University of Vermont Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bachmann's bundle area pacing
Lead placement in Bachmann's bundle area
Procedure: 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
Procedure: Right atrial appendage lead placement
Atrial lead placement in the right atrial appendage

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Vermont

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2021

Primær færdiggørelse (Forventet)

1. juni 2023

Studieafslutning (Forventet)

1. juni 2023

Datoer for studieregistrering

Først indsendt

15. november 2021

Først indsendt, der opfyldte QC-kriterier

27. november 2021

Først opslået (Faktiske)

10. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 00001532

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

De-identified data upon reasonable request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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