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Intramural Needle Ablation for Ventricular Tachycardia

14. marts 2022 opdateret af: John Sapp

Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation

This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.

Data Collection:

Baseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.

Procedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.

Followup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

4

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.

Beskrivelse

Inclusion Criteria:

  • Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.

Exclusion Criteria:

  • Patient refusal to participate

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Recurrent VT failing RF ablation
Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Freedom from hospitalization for recurrent VT during 6 months following ablation
Tidsramme: 6 months
Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation
6 months
Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure
Tidsramme: 6 months
Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Procedural Success
Tidsramme: 6 hours
Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible
6 hours
Acute procedural complications
Tidsramme: 24 hours
Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure
24 hours
Number of inducible VT morphologies
Tidsramme: 6 hours
Number of VT morphologies induced during catheter ablation
6 hours
ICD therapy - shocks
Tidsramme: 3 months
Number of VT events treated with appropriate ICD shocks at 3 months post procedure
3 months
ICD therapy - shocks
Tidsramme: 6 months
Number of VT events treated with appropriate ICD shocks at 6 months post procedure
6 months
ICD therapy - ATP
Tidsramme: 3 months
Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure
3 months
ICD therapy - ATP
Tidsramme: 6 months
Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure
6 months
ICD Therapy
Tidsramme: 3 months
Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure
3 months
ICD Therapy
Tidsramme: 6 months
Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure
6 months
VT storm
Tidsramme: 3 months
Number of VT storm events during 3 months follow-up
3 months
VT storm
Tidsramme: 6 months
Number of VT storm events during 6 months follow-up
6 months
VT events
Tidsramme: 3 months
Difference in number of VT events during 3 months prior to and following procedure
3 months
VT events
Tidsramme: 6 months
Difference in number of VT events during 6 months prior to and following procedure
6 months
Recurrent VT
Tidsramme: 6 months
Time to first recurrent VT
6 months
Appropriate ATP
Tidsramme: 6 months
Time to first appropriate ATP
6 months
Appropriate ICD shock
Tidsramme: 6 months
Time to first appropriate ICD shock
6 months
VT Storm
Tidsramme: 6 months
Time to first VT storm
6 months
Antiarrhythmic Drug Therapy
Tidsramme: 6 months
Changes in antiarrhythmic drug therapy post-procedure
6 months
Total appropriate ICD shocks
Tidsramme: 3 months
Total number of appropriate ICD shocks during 3 months follow up
3 months
Total appropriate ICD shocks
Tidsramme: 6 months
Total number of appropriate ICD shocks during 6 months follow up
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

John Sapp

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)

1. juli 2016

Primær færdiggørelse (Faktiske)

5. april 2018

Studieafslutning (Faktiske)

30. maj 2018

Datoer for studieregistrering

Først indsendt

2. juni 2016

Først indsendt, der opfyldte QC-kriterier

10. juni 2016

Først opslået (Skøn)

15. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Sapp002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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