Ventricular TachycardiaERASE-VTNCT01182389
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
A study testing Robotic VT Ablation and Conventional Therapy in people with Ventricular Tachycardia, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's rhythm back to normal by electrically… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Robotic VT Ablation and Conventional Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2011to Feb 2016
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females eighteen (18) to eighty-five (85) years old
- ICD implantation for post-infarct primary or secondary prophylaxis
- First episode of VT detected (within monitor zone or therapy (ATP /shock delivered) or by 12 lead ECG if the rate below the detection level of the device.
- Suitable candidate for catheter ablation
- Signed informed consent
Who cannot join
- Contraindication to catheter ablation
- Ventricular tachycardia due to transient, reversible causes
- Presence of a left ventricular thrombus
- Severe cerebrovascular disease
- Active gastrointestinal bleeding
- Renal failure (on dialysis or at risk of requiring dialysis)
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- Active infection or fever
- Life expectancy shorter than the duration of the trial
- Allergy to contrast
- Intractable heart failure (NYHA Class IV)
- Bleeding or clotting disorders or inability to receive heparin
- Serum [K+] <3.5 or >5.0mmol/L
- Serum Creatinine >200umol/L
- Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
- Malignancy needing therapy
- Pregnancy or women of child-bearing potential not using a highly effective method of contraception
- Unable to give informed consent
- Unable to attend follow-up in ICD clinics
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St Bartholomew's Hospital
London, EC1A 7BE
Hammersmith Hospital, Imperial College Healthcare
London, W120HS
John Radcliffe Hospital
Oxford, OX3 9DU
About this study
Official title: A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's rhythm back to normal by electrically stimulating the heart but in doing so gives the patient painful and debilitating shocks. The first ICD shock after implantation appears to be a powerful predictor of subsequent shock therapy as well as being a predictor of of increased mortality in patients with primary prevention ICDs. In patients who receive repeated shocks VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem. However, it is often only performed as a last resort as it is technically challenging. We believe that performing VT ablation using the robotic system early after the first episode of VT after ICD implantation, may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life.
200 patients from 5 european countries will be recruited in a prospective, open, randomised trial. Eligible, consenting patients who have experienced their first episode of VT since ICD implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or standard 'conventional' therapy and followed-up every 4 months over two years to assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.
- Conditions
- Ventricular Tachycardia
- Being tested
- Robotic VT Ablation, Conventional Therapy
- Keywords
- Ventricular Tachycardia, Implantable Cardioverter Defibrillator, Catheter Ablation, Robotic
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic VT AblationProcedure or surgery
Robotic VT Ablation
Conventional TherapyOther
Review of ICD programming to ensure that detection and therapy will occur appropriately
| Study group | Role | What they receive |
|---|---|---|
| robotic VT Ablation | Active comparator | Robotic VT ablation by substrate elimination Receives: Procedure: Robotic VT Ablation |
| Conventional therapy | Active comparator | review of ICD programming to ensure that detection and therapy will occur appropriately. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any appropriate ICD therapy
Measured: 24 months post randomisation
Secondary outcomes (5)
Treatment Failures defined as either2 ICD shocks or 5 ATP episodes
Measured: 24 months post randomisation
Total therapy rate
Measured: 24 months post randomisation
Mortality
Measured: 24 months post randomisation
All cause hospitalisation
Measured: 24 months post randomisation
Quality of Life
Measured: 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionFeb 2016
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Hansen Medical
- Responsible party
- Sponsor
- Investigators
- Prapa Dr Kanagaratnam, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182389
- Sponsor's protocol ID
- CRO1631
- Acronym
- ERASE-VT
- Status last verified
- Feb 2016
- First submitted
- 13 Aug 2010
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT01182389
- Acronym / sponsor ID
- ERASE-VT / CRO1631
- Conditions
- Ventricular Tachycardia
- Keywords
- Ventricular Tachycardia, Implantable Cardioverter Defibrillator, Catheter Ablation, Robotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Hansen Medical
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Aug 2010 (estimated)
- 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.
Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's rhythm back to normal by electrically stimulating the heart but in doing so gives the patient painful and debilitating shocks. The first ICD shock after implantation appears to be a powerful predictor of subsequent shock therapy as well as being a predictor of of increased mortality in patients with primary prevention ICDs. In patients who receive repeated shocks VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem. However, it is often only performed as a last resort as it is technically challenging. We believe that performing VT ablation using the robotic system early after the first episode of VT after ICD implantation, may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life.
200 patients from 5 european countries will be recruited in a prospective, open, randomised trial. Eligible, consenting patients who have experienced their first episode of VT since ICD implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or standard 'conventional' therapy and followed-up every 4 months over two years to assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic VT Ablation | Active comparator | Procedure: Robotic VT AblationRobotic VT ablation by substrate elimination |
| Conventional therapy | Active comparator | Other: Conventional Therapyreview of ICD programming to ensure that detection and therapy will occur appropriately. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females eighteen (18) to eighty-five (85) years old
- ICD implantation for post-infarct primary or secondary prophylaxis
- First episode of VT detected (within monitor zone or therapy (ATP /shock delivered) or by 12 lead ECG if the rate below the detection level of the device.
- Suitable candidate for catheter ablation
- Signed informed consent
Key exclusion criteria (18 listed)
- Contraindication to catheter ablation
- Ventricular tachycardia due to transient, reversible causes
- Presence of a left ventricular thrombus
- Severe cerebrovascular disease
- Active gastrointestinal bleeding
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 |
|---|---|---|
| Robotic VT AblationRobotic VT Ablation | Procedure or surgery | robotic VT Ablation |
| Conventional TherapyReview of ICD programming to ensure that detection and therapy will occur appropriately | Other | Conventional therapy |
Primary outcome
Any appropriate ICD therapy
Time frame: 24 months post randomisation
5 secondary outcomes
Treatment Failures defined as either2 ICD shocks or 5 ATP episodes
Time frame: 24 months post randomisation
Total therapy rate
Time frame: 24 months post randomisation
Mortality
Time frame: 24 months post randomisation
All cause hospitalisation
Time frame: 24 months post randomisation
Quality of Life
Time frame: 12 months post randomisation
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 5 Sep 2017.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Prapa Dr Kanagaratnam principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic VT Ablation and Conventional Therapy in people with Ventricular Tachycardia, run by Imperial College London at 3 sites in United Kingdom.
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 5 inclusion and 18 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Any appropriate ICD therapy (time frame: 24 months post randomisation). 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 5 Sep 2017.