- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02799693
Intramural Needle Ablation for Ventricular Tachycardia
Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
Studieöversikt
Status
Betingelser
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
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 3A7
- QEII Health Sciences Centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.
Exclusion Criteria:
- Patient refusal to participate
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
|---|
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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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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
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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
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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
|
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Appropriate ATP
Tidsram: 6 months
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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
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Sapp002
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