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Intramural Needle Ablation for Ventricular Tachycardia

14 mars 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal to participate

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Freedom from hospitalization for recurrent VT during 6 months following ablation
Tidsram: 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
Tidsram: 6 months
Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acute Procedural Success
Tidsram: 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
Tidsram: 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
Tidsram: 6 hours
Number of VT morphologies induced during catheter ablation
6 hours
ICD therapy - shocks
Tidsram: 3 months
Number of VT events treated with appropriate ICD shocks at 3 months post procedure
3 months
ICD therapy - shocks
Tidsram: 6 months
Number of VT events treated with appropriate ICD shocks at 6 months post procedure
6 months
ICD therapy - ATP
Tidsram: 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
Tidsram: 6 months
Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure
6 months
ICD Therapy
Tidsram: 3 months
Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure
3 months
ICD Therapy
Tidsram: 6 months
Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure
6 months
VT storm
Tidsram: 3 months
Number of VT storm events during 3 months follow-up
3 months
VT storm
Tidsram: 6 months
Number of VT storm events during 6 months follow-up
6 months
VT events
Tidsram: 3 months
Difference in number of VT events during 3 months prior to and following procedure
3 months
VT events
Tidsram: 6 months
Difference in number of VT events during 6 months prior to and following procedure
6 months
Recurrent VT
Tidsram: 6 months
Time to first recurrent VT
6 months
Appropriate ATP
Tidsram: 6 months
Time to first appropriate ATP
6 months
Appropriate ICD shock
Tidsram: 6 months
Time to first appropriate ICD shock
6 months
VT Storm
Tidsram: 6 months
Time to first VT storm
6 months
Antiarrhythmic Drug Therapy
Tidsram: 6 months
Changes in antiarrhythmic drug therapy post-procedure
6 months
Total appropriate ICD shocks
Tidsram: 3 months
Total number of appropriate ICD shocks during 3 months follow up
3 months
Total appropriate ICD shocks
Tidsram: 6 months
Total number of appropriate ICD shocks during 6 months follow up
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2016

Primärt slutförande (Faktisk)

5 april 2018

Avslutad studie (Faktisk)

30 maj 2018

Studieregistreringsdatum

Först inskickad

2 juni 2016

Först inskickad som uppfyllde QC-kriterierna

10 juni 2016

Första postat (Uppskatta)

15 juni 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

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