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Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial (CARA-VT RCT)

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ClinicalTrials.gov Identifier: NCT05047198
Recruitment Status : Not yet recruiting
First Posted : September 17, 2021
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Calum Redpath, Ottawa Heart Institute Research Corporation

Brief Summary:
This study compares two arms - the current standard of care catheter ablation for Ventricular Tachycardia compared to stereotactic radiotherapy to non-invasively ablate ventricular tachycardia using a novel non-invasive ECG based body surface mapping technology. This allows investigators to identify ventricular tachycardia circuits to target for subsequent radio ablation. To summarize, the current standard of care invasive catheter ablation to the non-invasive radio ablation.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Procedure: Control - Catheter Ablation for VT Procedure: Treatment - Non-Invasive Radio Ablation for VT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, vanguard non-inferiority, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
Estimated Study Start Date : May 15, 2022
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 15, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Catheter Ablation using invasive mapping
Procedure: Control - Catheter Ablation for VT
Currently standard of care involves surgical resection of myocardial scarring in structural heart disease. Imaging is performed to identify culprit areas for ablation, pre procedural imaging involves echocardiography, CT scanning and PET imaging to assess cardiac function, ischemia, inflammation and scarring. Radiofrequency energy is delivered via catheter to the targets and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. A conventional approach will be used advancing multiple catheters via femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, "scar", identified during endocardial mapping. CA procedures for VT are often long, averaging approximately 5 hours .

Experimental: Treatment
Radio-ablation using non-invasive mapping
Procedure: Treatment - Non-Invasive Radio Ablation for VT
Patients undergoing a non-invasive RA procedure for VT similarly require medical stabilization and multimodal imaging prior to treatment. A non-invasive electrophysiology study is performed under light sedation using ECGi mapping. This procedure requires only the placement of an IV cannula for light sedation, uses the ICD to stimulate VT which is mapped in real time using the ECGi mapping system. The multimodal imaging data is digitally fused and combined with the ECGi data to identify the VT circuit(s) and to attain the targets for radio-ablation. This analogue process is performed off-line by a physician team. The treatment plan is sent for alignment on a 4D planning CT performed with breath holding in the radiotherapy suite. Final treatment targets are reviewed by the local treating team and discussed with our collaborators remotely. Thereafter the patient is booked for a 15 minute out-patient radiotherapy treatment performed on a standard linear accelerator.




Primary Outcome Measures :
  1. Time to composite event [ Time Frame: 14 days ]
    Composite event including death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days, treated sustained ventricular tachycardia below the detection rate of the ICD after 14 days


Secondary Outcome Measures :
  1. Appropriate ICD ATP at any time or after 14 days [ Time Frame: at any time or after 14 days ]
    Any appropriate therapy delivered from the ICD at least 14 days post randomization

  2. Appropriate shocks [ Time Frame: at any time or after 14 days ]
    Appropriate ICD shocks at any time post randomization

  3. VT storm at any time or after 14 days [ Time Frame: at any time or after 14 days ]
    3 or more episodes of VT occurring within 24 hours at any time post randomization

  4. Sustained VT not treated by ICD at any time or after 14 days [ Time Frame: at any time or after 14 days ]
    Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days Any sustained VT greater than 30 seconds requiring manual cardioversion (ICD, external or pharmacologic)

  5. Inappropriate ICD shocks at any time or after 14 days [ Time Frame: at any time or after 14 days ]
    All inappropriate shocks from the ICD at any time post randomization

  6. Any ICD shock at any time or after 14 days [ Time Frame: at any time or after 14 days ]
    Both appropriate and inappropriate shocks from the ICD at any time post randomization

  7. Any ventricular arrhythmia event at any time or after 14 days [ Time Frame: at any time or after 14 days ]

    All ventricular arrhythmias including a composite of: appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion), VT storm/incessant VT.

    (composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion)


  8. Number of ICD shocks (all cause) [ Time Frame: 3 years ]
    The number of all shocks from any cause will be calculated

  9. Number of Anti-tachycardia pacing (ATP) [ Time Frame: 3 years ]
    The total of all ATP delivered from the ICD will be calculated

  10. Number of ICD appropriate therapy [ Time Frame: 3 years ]
    Total number of therapies which received appropriate ICD therapy

  11. Number of VT storm events [ Time Frame: 3 years ]
    Total number of VT storms (3 episodes of VT within 24 hours)/ incessant VT will be calculated

  12. Number of ventricular arrhythmia events [ Time Frame: 3 years ]
    This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, or VT storm/incessant VT. VT events which do not terminate despite exhausting ICD therapies will be considered incessant VT and included within the definition of VT storm.

  13. Hospital admission for cardiac causes [ Time Frame: 3 years ]
    Hospitalizations greater than 24 hours due to a cardiovascular cause.

  14. Heart Failure decompensation /death [ Time Frame: 3 years ]
    LVEF and RVEF assessed on 6-month and 24 month echocardiogram (absolute and delta compared to baseline).

  15. Procedural complications and/ or antiarrhythmic drug adverse effects [ Time Frame: 3 years ]
    and Periprocedural complications and adverse drug reactions will be assessed, any dose change or discontinuation of anti-arrhythmic medication due to abnormal blood tests (including kidney function, liver function, thyroid function) or any perceived side effects.

  16. Patient Quality of life - SF36 [ Time Frame: 3 years ]
    Will include responses from the Short Form 36

  17. Cost-effectiveness [ Time Frame: 3 years ]
    Quality adjusted life years (QALYs) will be derived from the case report forms and the questionnaires

  18. Escalation and De-escalation of antiarrhythmic medication [ Time Frame: 3 years ]
    Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed and reviewed.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient aged ≥55 years of age
  2. Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND
  3. Recurrent VT events despite previous CA OR
  4. VT events requiring intervention and PAINESD score ≥ 15

Exclusion Criteria:

  1. Patients with NYHA Class IV heart failure &/ or with LVAD in situ
  2. Patients not expected to live for more than one year for any reason
  3. Patients who have previously received thoracic radiotherapy
  4. Patients who are enrolled in another randomized clinical trial
  5. Patients who are unable or unwilling to provide informed consent
  6. Patients aged ≤54 years of age
  7. Pregnancy (all women of child bearing age and potential will have a negative β-HCG test before enrollment)
  8. Breastfeeding
  9. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception (IUD, sterilization, birth control implant or birth control pill) throughout the study.

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): NCT05047198


Contacts
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Contact: Calum Redpath 6136967000 credpath@ottawaheart.ca
Contact: Tammy Knight 6136967000 ext 19080 tknight@ottawaheart.ca

Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Calum Redpath Ottawa Heart Institute Research Corporation
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Responsible Party: Calum Redpath, Staff Electrophysiologist / Associate Professor of Medicine, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05047198    
Other Study ID Numbers: 06-2021
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes