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Trial record 5 of 133 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

Intramural Needle Ablation for Ventricular Tachycardia

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ClinicalTrials.gov Identifier: NCT02799693
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
John Sapp, Nova Scotia Health Authority

Brief Summary:
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.

Condition or disease
Recurrent Ventricular Tachycardia

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Freedom from hospitalization for recurrent VT during 6 months following ablation [ Time Frame: 6 months ]
    Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation

  2. Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure [ Time Frame: 6 months ]
    Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.


Secondary Outcome Measures :
  1. Acute Procedural Success [ Time Frame: 6 hours ]
    Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible

  2. Acute procedural complications [ Time Frame: 24 hours ]
    Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure

  3. Number of inducible VT morphologies [ Time Frame: 6 hours ]
    Number of VT morphologies induced during catheter ablation

  4. ICD therapy - shocks [ Time Frame: 3 months ]
    Number of VT events treated with appropriate ICD shocks at 3 months post procedure

  5. ICD therapy - shocks [ Time Frame: 6 months ]
    Number of VT events treated with appropriate ICD shocks at 6 months post procedure

  6. ICD therapy - ATP [ Time Frame: 3 months ]
    Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure

  7. ICD therapy - ATP [ Time Frame: 6 months ]
    Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure

  8. ICD Therapy [ Time Frame: 3 months ]
    Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure

  9. ICD Therapy [ Time Frame: 6 months ]
    Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure

  10. VT storm [ Time Frame: 3 months ]
    Number of VT storm events during 3 months follow-up

  11. VT storm [ Time Frame: 6 months ]
    Number of VT storm events during 6 months follow-up

  12. VT events [ Time Frame: 3 months ]
    Difference in number of VT events during 3 months prior to and following procedure

  13. VT events [ Time Frame: 6 months ]
    Difference in number of VT events during 6 months prior to and following procedure

  14. Recurrent VT [ Time Frame: 6 months ]
    Time to first recurrent VT

  15. Appropriate ATP [ Time Frame: 6 months ]
    Time to first appropriate ATP

  16. Appropriate ICD shock [ Time Frame: 6 months ]
    Time to first appropriate ICD shock

  17. VT Storm [ Time Frame: 6 months ]
    Time to first VT storm

  18. Antiarrhythmic Drug Therapy [ Time Frame: 6 months ]
    Changes in antiarrhythmic drug therapy post-procedure

  19. Total appropriate ICD shocks [ Time Frame: 3 months ]
    Total number of appropriate ICD shocks during 3 months follow up

  20. Total appropriate ICD shocks [ Time Frame: 6 months ]
    Total number of appropriate ICD shocks during 6 months follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799693


Contacts
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Contact: John L Sapp, MD FRCPC 902 473 4272 john.sapp@nshealth.ca

Locations
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Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Johns Sapp, MD, FRCPC    902 473 4272    john.sapp@nshealth.ca   
Contact: Karen Giddens    902 473 2758    karen.giddens@nshealth.ca   
Principal Investigator: Sapp John, MD, FRCPC         
Sponsors and Collaborators
John Sapp
Investigators
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Principal Investigator: John Sapp, MD FRCPC Nova Scotia Health Authority

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Responsible Party: John Sapp, MD FRCPC FRHS, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02799693     History of Changes
Other Study ID Numbers: Sapp002
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Sapp, Nova Scotia Health Authority:
Catheter Ablation
Ventricular Tachycardia
Intramural Needle Catheter
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes