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Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia (CAAD-VT)

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ClinicalTrials.gov Identifier: NCT05524077
Recruitment Status : Recruiting
First Posted : September 1, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Saurabh Kumar, Western Sydney Local Health District

Brief Summary:

Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important clinical sequela in patients with structural heart disease. VT generally occurs as a result of electrical re-entry in the presence of arrhythmogenic substrate (scar). Scar tissue forms due to an ischemic cardiomyopathy (ICM) from prior coronary obstructive disease or a non-ischemic cardiomyopathy (NICM) from an inflammatory or genetic disease.

AADs can reduce VT recurrence, but have significant limitations in treatment of VT. For example, amiodarone has high rates of side effects/toxicities and a finite effective usage before recurrence. ICDs prevent cardiac arrest and sudden death from VT, but do not stop VT occurring. Recurrent VT and ICD therapies decrease QOL, increase hospital visits, mortality, morbidity and risk of death. Improvement in techniques for mapping and ablation of VT have made CA an alternative.

Currently, there is limited evidence to guide clinicians either toward AAD therapy or CA in patients with NICM. This data shows significant benefit of CA over medical therapy in terms of VT free survival, survival free of VT storm and VT burden. Observational studies suggest that CA is effective in eliminating VT in NICM patients who have failed AADs, resulting in reduction of VT burden and AAD use over long term follow up. Furthermore, there is limited data on the efficacy of CA in early ICM with VT, or advanced ICM with VT. RCT data is almost exclusively on patients with modest ICM with VT, and this is not representative of the real-world scenario of patients with structural heart disease presenting with VT.

Therefore the primary objective is to determine in all patients with structural heart disease and spontaneous or inducible VT, if catheter ablation compared to standard medical therapy with anti-arrhythmic drugs results in a reduction of a composite endpoint of recurrent VT, VT storm and death at a median follow up of 18 months.


Condition or disease Intervention/treatment Phase
Heart Disease Structural Disorder Ventricular Tachycardia Cardiomyopathy, Dilated Sarcoidosis Cardiomyopathy, Hypertrophic Cardiomyopathy Ischemic Cardiomyopathy, Familial Arrhythmogenic Right Ventricular Cardiomyopathy 1 Arrhythmogenic Left Ventricular Cardiomyopathy Procedure: Ablation Drug: Anti-arrhythmic Drugs (AADs) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Randomisation will be performed using a secure, password-protected web portal (REDCap) and the allocation sequence will be blinded to investigators and participants until the participants have been deemed eligible and enrolled in the study. It will not be possible to maintain blinding after study enrolment because the intervention is invasive.

Outcome verification will be blinded.

Primary Purpose: Treatment
Official Title: Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia (CAAD-VT): A Randomised Trial
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026


Arm Intervention/treatment
Experimental: Ablation

Patients will be expected to have a catheter ablation procedure within 2 weeks post randomisation and no longer than 30 days post randomisation.

Medical therapy can be used as a temporising measure before catheter ablation, as is standard of care. If there is breakthrough VT during the period before the clinical procedure, standard practice will be followed in stabilising the ventricular tachycardia (VT) including intravenous short acting anti-arrhythmic drugs (AAD), admission to hospital, internal or external cardioversion. However, preference will be given to scheduling the procedure within 24-48 hours in this situation.

Procedure: Ablation

Catheter ablation (CA) will be performed in the standard fashion (described in international guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death from the AHA/ACC/HRS and the expert consensus statement on Catheter Ablation of Ventricular Arrhythmias from HRS/EHRA/APHRS/LAHRS). CA will be performed under conscious sedation or GA by an Electrophysiologist trained in cardiac arrhythmia ablation. CA will be guided by a combination of mapping techniques (standard practice), and described in guidelines for CA for VT. Mapping techniques will include pace, entrainment, activation, and electro-anatomic substrate mapping, where haemodynamically tolerated. Expected procedure duration is 3-6hrs.

Post-CA, AAD is stopped if patient was drug naïve pre-randomisation. The baseline type/dose of AAD pre-randomisation is continued if the patient was on an AAD pre-randomisation. Repeat ablations are permitted within 30-days post-randomisation.


Active Comparator: Anti-arrhythmic drugs (AAD)
Patients managed with medical therapy alone by their usual medical practitioners. A protocol aligned with standard clinical care/current clinical guidelines will be provided for guidance, the objective being that the control arm replicates what would constitute standard of care for patients with ventricular tachycardia managed with a non-interventional approach.
Drug: Anti-arrhythmic Drugs (AADs)

Standard care usually encompasses patients who have not previously had AADs, being commenced on sotalol 80mg twice/day. Lower doses may be initiated by treating doctor, as clinically indicated. If there is contraindication to sotalol, another beta-blocker may be initiated using standard doses. Clinicians may consider alternative AADs if there is contraindication to beta-blockers. Doses would be up titrated to the maximal tolerated amount.

For patients already on an AAD, amiodarone would usually be added, as per VANISH trial.

They will receive a loading dose 400mg twice/day for 2 weeks, followed by 400mg/day for 4 weeks and 200mg/day thereafter. Patients who have "failed" amiodarone dose <300mg/day will receive a repeat loading dose of 400mg twice/day for 2 weeks, followed by 400mg/day for 1 week, and 300mg/day thereafter.

If the treating doctor decides to do a CA for VT, the occurrence and timepoint of cross-over will be recorded. Cross-over is estimated to be <2% (VANISH trial).





Primary Outcome Measures :
  1. Composite of Recurrent VT or VT storm [ Time Frame: Primary outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. VT/VT Storm events after the 30-day treatment 'blanking' period after treatment initiation will be included. ]

    VT (detected by cardiac device as lasting ≥30 seconds or shorter in duration if treated by the ICD).

    VT storm (three or more documented episodes of VT within 24 hours or incessant VT).


  2. Death [ Time Frame: Primary outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Death events at any time after randomisation will be included. ]
    Death (at any time) due to any cause.


Secondary Outcome Measures :
  1. Recurrent sustained VT [ Time Frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. VT events will be included after the 30-day treatment 'blanking' period after treatment initiation. ]
    Recurrent sustained VT detected by implanted cardioverter defibrillator (ICD) (VT identified and treated by the ICD with anti-tachycardia pacing (ATP) and/or internal ICD delivered shock or ≥30 seconds of VT if untreated by ICD)

  2. VT storm [ Time Frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. VT storm events will be included after the 30-day treatment 'blanking' period after treatment initiation. ]
    Three or more documented episodes of VT within 24 hours or incessant VT

  3. VT burden [ Time Frame: 6 months after randomisation, with a 30-day treatment 'blanking' period after treatment initiation; and 6 months before randomisation ]
    VT burden (number of episodes of VT in the preceding 6 months compared to the 6 months after randomisation and therapy)

  4. Cardiovascular hospitalisation [ Time Frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Events will be included after the 30-day treatment 'blanking' period after treatment initiation. ]
    All cardiovascular hospitalisation; heart failure; hospitalisation for arrhythmia

  5. Mortality [ Time Frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Events will be included at any time after randomisation. ]
    All-cause mortality; cardiovascular mortality; non-cardiac death

  6. Effect of intervention on ventricular function [ Time Frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Events will be included after the 30-day treatment 'blanking' period after treatment initiation. ]
    Effect of intervention on ventricular function as assessed by transthoracic echocardiography from baseline to 6-, 12-, 24- and 36-months' post intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be eligible for inclusion if they have:

  1. ≥1 prior episode of sustained VT in the prior 6 months;

    1. Spontaneous VT: ≥1 episode of monomorphic VT treated by anti-tachycardia pacing (ATP) and/or internal shock by an ICD; lasting ≥30 seconds in the absence of intra-cardiac device therapy that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
    2. Spontaneous VT: ≥1 episode of sustained spontaneous monomorphic VT lasting ≥30 seconds documented on Holter, ECG, Loop recorder or other cardiac monitoring device that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
    3. Inducible VT: with syncope or palpitations - inducible VT defined as sustained monomorphic VT of CL ≥200 ms lasting for ≥10 s during a cardiac electrophysiology study (note with 4 extrastimuli with or without provocation with isoprenaline);
  2. Already a recipient of an implanted cardiac device such as a pacemaker, defibrillator or a cardiac resynchronisation therapy device and/or is indicated to receive one given a new diagnosis of structural heart disease, based on current guideline recommendations;
  3. Aged ≥18 years.

Exclusion Criteria:

Patients will be excluded if they are:

  1. Unable or unwilling to provide informed consent or patients physician feels there is not significant equipoise to justify randomisation;
  2. Women who are pregnant, breast feeding;
  3. Medical illness with an anticipated life expectancy <3 months;
  4. Unable to complete study procedures or unwilling to be followed up;
  5. Have a concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments;
  6. Known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergic polymorphic VT;
  7. Known prior diagnosis of no structural heart disease, or idiopathic ventricular arrhythmia.

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): NCT05524077


Contacts
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Contact: Saurabh Kumar, MBBS, PhD +61288908140 saurabh.kumar@health.nsw.gov.au
Contact: Timothy Campbell, BSc timothy.campbell@sydney.edu.au

Locations
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Australia, Australian Capital Territory
The Canberra Hospital Not yet recruiting
Garran, Australian Capital Territory, Australia, 2605
Contact: Rajeev Pathak, MBBS, PhD         
Principal Investigator: Rajeev Pathak, MBBS, PhD         
Australia, New South Wales
Blacktown Hospital Recruiting
Blacktown, New South Wales, Australia, 2148
Contact: Pierre Qian, MBBS, PhD         
Principal Investigator: Pierre Qian, MBBS, PhD         
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Kim Chan         
Principal Investigator: Kim Chan, MBBS, PhD         
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Ihab El-Sokkari, MBBCh         
Principal Investigator: Ihab El-Sokkari, MBBCh         
John Hunter Hospital Recruiting
New Lambton Heights, New South Wales, Australia, 2305
Contact: Nicholas Jackson, MBBS         
Principal Investigator: Nicholas Jackson, MBBS         
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Contact: Karin Chia, MBBS, PhD         
Principal Investigator: Karin Chia, MBBS, PhD         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Saurabh Kumar, MBBS, PhD         
Principal Investigator: Saurabh Kumar, MBBS, PhD         
Australia, Queensland
The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Haris Haqqani, MBBS, PhD         
Principal Investigator: Haris Haqqani, MBBS, PhD         
Gold Coast University Hospital Recruiting
Southport, Queensland, Australia, 4215
Contact: Matthew Rowe, MBBS         
Principal Investigator: Matthew Rowe, MBBS         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Kurt Roberts-Thomson, MBBS, PhD         
Principal Investigator: Kurt Roberts-Thomson, MBBS, PhD         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Peter Kistler, MBBS, PhD         
Principal Investigator: Peter Kistler, MBBS, PhD         
The Royal Melbourne Hospital Not yet recruiting
Parkville, Victoria, Australia, 3050
Contact: Geoffrey Lee, MBChB, PhD         
Principal Investigator: Geoffrey Lee, MBChB, PhD         
Sponsors and Collaborators
Western Sydney Local Health District
Investigators
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Principal Investigator: Saurabh Kumar, MBBS, PhD Western Sydney Local Health District
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Responsible Party: Saurabh Kumar, Staff Specialist Cardiologist, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT05524077    
Other Study ID Numbers: CAAD-VT
First Posted: September 1, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 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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Heart Diseases
Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Cardiomyopathy, Dilated
Arrhythmogenic Right Ventricular Dysplasia
Cardiomyopathy, Hypertrophic
Sarcoidosis
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Cardiomegaly
Laminopathies
Genetic Diseases, Inborn
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Anti-Arrhythmia Agents