Ventricular TachycardiaRAPIDVTPilotNCT03523286
Real-time Automated Program for IDentification of VT Origin
A study testing RAPID-VT Software guided ablation in people with Ventricular Tachycardia and Ischemic Heart Disease, run by Amir AbdelWahab at 1 site in Canada.
Trial summary
RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Heart Disease
- What is being tested?
- RAPID-VT Software guided ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:
- Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and
- One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug:
- A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD
Who cannot join
- Patients will be excluded from the trial if they:
- Are unable or unwilling to provide informed consent.
- Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization.
- Are antiarrhythmic drug-naïve.
- Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves.
- Have had a prior catheter ablation procedure for VT.
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- Are in renal failure (Creatinine clearance <15 mL/min)
- Have NYHA Functional class IV heart failure or CCS Functional class IV angina.
- Have had recent ST elevation myocardial infarction (< 1 month).
- Are pregnant or have a systemic illness likely to limit survival to <1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Automated Program for IDentification of VT Origin - Pilot Study
RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.
Read the detailed description
Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration.
During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites.
Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.
- Conditions
- Ventricular Tachycardia, Ischemic Heart Disease
- Being tested
- RAPID-VT Software guided ablation
- Keywords
- Catheter ablation, ECG imaging
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPID-VT Software guided ablationOther
Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software
| Study group | Role | What they receive |
|---|---|---|
| RAPID-VT Software guided ablation | Experimental | The induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation Receives: Other: RAPID-VT Software guided ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inducibility of VT
Lack of any inducible VT at the end of the ablation procedure
Measured: At end of ablation procedure
Secondary outcomes (6)
Procedure efficacy measure: VT(s) ablated
Number of VTs identified and targeted with ablation
Measured: At end of procedure
Procedure efficacy measure: Procedure duration
Duration of procedure in minutes
Measured: At end of procedure
Procedure efficacy measure: VT recurrence
Time to recurrence of VT in months
Measured: During follow up period of 6 months
Procedure safety measure: Acute complications
Incidence of any procedure-related complications
Measured: At end of procedure and at 30 days of follow up
Procedure safety measure: Clinical heart failure worsening
Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT
Measured: At end of procedure, at 30 days and 6 months of follow up
Procedure safety measure: Mortality and hospitalization for cardiac causes
Death and/or cardiac hospitalization
Measured: At 30 days and 6 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Oct 2018
- Primary completion1 Nov 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amir AbdelWahab
- Sponsor type
- University, hospital or other
- Collaborators
- Maritime Heart Centre
- Responsible party
- Sponsor-investigator, Amir AbdelWahab, Nova Scotia Health Authority
- Investigators
- Amir AbdelWahab, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523286
- Sponsor's protocol ID
- 6201
- Acronym
- RAPIDVTPilot
- Status last verified
- Feb 2023
- First submitted
- 9 Apr 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Automated Program for IDentification of VT Origin - Pilot Study
- ClinicalTrials.gov ID
- NCT03523286
- Acronym / sponsor ID
- RAPIDVTPilot / 6201
- Conditions
- Ventricular Tachycardia, Ischemic Heart Disease
- Keywords
- Catheter ablation, ECG imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Amir AbdelWahabUniversity, hospital or other
- Collaborators
- Maritime Heart Centre
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.
Detailed description
Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration.
During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites.
Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAPID-VT Software guided ablation | Experimental | Other: RAPID-VT Software guided ablationThe induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:
- A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD
Key exclusion criteria (10 listed)
- Patients will be excluded from the trial if they:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAPID-VT Software guided ablationCatheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software | Other | RAPID-VT Software guided ablation |
Primary outcome
Non-inducibility of VT
Time frame: At end of ablation procedure
Lack of any inducible VT at the end of the ablation procedure
6 secondary outcomes
Procedure efficacy measure: VT(s) ablated
Time frame: At end of procedure
Procedure efficacy measure: Procedure duration
Time frame: At end of procedure
Procedure efficacy measure: VT recurrence
Time frame: During follow up period of 6 months
Procedure safety measure: Acute complications
Time frame: At end of procedure and at 30 days of follow up
Procedure safety measure: Clinical heart failure worsening
Time frame: At end of procedure, at 30 days and 6 months of follow up
Procedure safety measure: Mortality and hospitalization for cardiac causes
Time frame: At 30 days and 6 months of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir AbdelWahab principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAPID-VT Software guided ablation in people with Ventricular Tachycardia and Ischemic Heart Disease, run by Amir AbdelWahab at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inducibility of VT (time frame: At end of ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.