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Intramural Needle Ablation for Ventricular Tachycardia
Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- QEII Health Sciences Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.
Exclusion Criteria:
- Patient refusal to participate
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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Recurrent VT failing RF ablation
Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Freedom from hospitalization for recurrent VT during 6 months following ablation
Tijdsspanne: 6 months
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Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation
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6 months
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Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure
Tijdsspanne: 6 months
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Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Acute Procedural Success
Tijdsspanne: 6 hours
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Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible
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6 hours
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Acute procedural complications
Tijdsspanne: 24 hours
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Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure
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24 hours
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Number of inducible VT morphologies
Tijdsspanne: 6 hours
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Number of VT morphologies induced during catheter ablation
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6 hours
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ICD therapy - shocks
Tijdsspanne: 3 months
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Number of VT events treated with appropriate ICD shocks at 3 months post procedure
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3 months
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ICD therapy - shocks
Tijdsspanne: 6 months
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Number of VT events treated with appropriate ICD shocks at 6 months post procedure
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6 months
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ICD therapy - ATP
Tijdsspanne: 3 months
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Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure
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3 months
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ICD therapy - ATP
Tijdsspanne: 6 months
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Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure
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6 months
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ICD Therapy
Tijdsspanne: 3 months
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Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure
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3 months
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ICD Therapy
Tijdsspanne: 6 months
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Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure
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6 months
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VT storm
Tijdsspanne: 3 months
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Number of VT storm events during 3 months follow-up
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3 months
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VT storm
Tijdsspanne: 6 months
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Number of VT storm events during 6 months follow-up
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6 months
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VT events
Tijdsspanne: 3 months
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Difference in number of VT events during 3 months prior to and following procedure
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3 months
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VT events
Tijdsspanne: 6 months
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Difference in number of VT events during 6 months prior to and following procedure
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6 months
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Recurrent VT
Tijdsspanne: 6 months
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Time to first recurrent VT
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6 months
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Appropriate ATP
Tijdsspanne: 6 months
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Time to first appropriate ATP
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6 months
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Appropriate ICD shock
Tijdsspanne: 6 months
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Time to first appropriate ICD shock
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6 months
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VT Storm
Tijdsspanne: 6 months
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Time to first VT storm
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6 months
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Antiarrhythmic Drug Therapy
Tijdsspanne: 6 months
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Changes in antiarrhythmic drug therapy post-procedure
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6 months
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Total appropriate ICD shocks
Tijdsspanne: 3 months
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Total number of appropriate ICD shocks during 3 months follow up
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3 months
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Total appropriate ICD shocks
Tijdsspanne: 6 months
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Total number of appropriate ICD shocks during 6 months follow up
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6 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Sapp002
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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