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Intramural Needle Ablation for Ventricular Tachycardia

14. mars 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Tilbakevendende ventrikkeltakykardi

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

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

Studiesteder

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

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

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Antall grupper / kohorter

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

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

Sponsor

John Sapp

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)

1. juli 2016

Primær fullføring (Faktiske)

5. april 2018

Studiet fullført (Faktiske)

30. mai 2018

Datoer for studieregistrering

Først innsendt

2. juni 2016

Først innsendt som oppfylte QC-kriteriene

10. juni 2016

Først lagt ut (Anslag)

15. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Sapp002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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