Ventricular TachycardiaNCT01974908
Fibrillatory Factor in Ventricular Tachycardia
A study testing Fibrillatory Factor calculation (FF) in people with Ventricular Tachycardia, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study involves recording electrical signals inside the heart during an ablation procedure. It is thought that by studying these electrical signals in detail the investigators may be able to better identify and treat patients at risk of Ventricular Tachycardia (VT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Fibrillatory Factor calculation (FF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Nov 2014
- 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
- Age 18 or above, and capable of giving informed consent
- Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia
Who cannot join
- Moderate or severe aortic stenosis or mitral stenosis
- Active infection
- Presence of thrombus, cardiac tumour, interatrial Baffle patch (a specific form of congenital cardiac surgery) or prior septal occluder device
- Subjects who cannot be anticoagulated of infused with heparinized saline
- A history of heparin induced thrombocytopenia
- Pregnant or actively breast feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas' NHS Trust
London, SE1 7EH
Jaswinder Gill, MD
About this study
Official title: Using Fibrillatory Factor to Predict the Source of Ventricular Tachycardia in Man
This study involves recording electrical signals inside the heart during an ablation procedure. It is thought that by studying these electrical signals in detail the investigators may be able to better identify and treat patients at risk of Ventricular Tachycardia (VT).
VT is where the lower chambers (ventricles) of your heart beat fast and this condition can be life-threatening. An ablation procedure is performed in patients who have VT despite the best treatment available with tablets.
Read more
Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by applying a type of electrical energy through a catheter. An important part of the ablation procedure is the identification of the exact part of the heart muscle responsible for causing the VT. This typically involves sampling the electrical signals in lots of different areas of the heart, which allows the construction of computer generated 3 dimensional pictures of the structure and the electrical circuits inside the ventricle. Recent research has identified a new method to interpret these electrical signals (called Fibrillatory Factor - FF), which may allow better identification of the area within the ventricle that should be ablated.
A standard VT ablation will often involve us controlling the heart-beat by pacing the heart through 1 of the investigators catheters within the heart. The electrical response to pacing at different heart rates can often provide your doctor with information to help the ablation. This study will involve an additional period of pacing at different heart rates, during which the electrical response is measured in different areas around the ventricle. This will allow us to calculate areas of the ventricle, which the investigators new measure FF would predict to be the source of the VT. In the future this may then allow us to better identify patients who are at risk of VT, and to better locate the area that needs to be ablated.
- Conditions
- Ventricular Tachycardia
- Being tested
- Fibrillatory Factor calculation (FF)
- Keywords
- Ventricular Tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrillatory Factor calculation (FF)Procedure or surgery
During sinus rhythm these patients will undergo a simple pacing protocol to allow us to calculate FF, which is an area we would predict is mod likely to be the origin of their VT.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular Tachycardia (VT) | Experimental | Patients with VT will undergo a clinically indicated ablation of their VT Receives: Procedure: Fibrillatory Factor calculation (FF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrillatory Factor
To identify the proportion of clinical VT circuits which could be predicted during sinus rhythm from the calculation of fibrillation factor. The number of FF derived VT exit points which are successfully predicted blindly by the investigators (using the clinically derived VT exit point based on electrophysiology assessment and ablation) will be the primary endpoint.
Measured: 18 months
Secondary outcomes (1)
Real-time fibrillatory factor
Having established that fibrillatory factor (FF) can predict VT circuits we will then develop our software further so that we can calculate FF in real-time. This will then be used in further research studies to guide invasive mapping.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaswinder Gill, M.D., Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Jaswinder Gill, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974908
- Sponsor's protocol ID
- GSTT-FF-1
- Status last verified
- Oct 2013
- First submitted
- 13 Jul 2013
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Fibrillatory Factor to Predict the Source of Ventricular Tachycardia in Man
- ClinicalTrials.gov ID
- NCT01974908
- Acronym / sponsor ID
- GSTT-FF-1
- Conditions
- Ventricular Tachycardia
- Keywords
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- First posted
- 4 Nov 2013 (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.
This study involves recording electrical signals inside the heart during an ablation procedure. It is thought that by studying these electrical signals in detail the investigators may be able to better identify and treat patients at risk of Ventricular Tachycardia (VT).
VT is where the lower chambers (ventricles) of your heart beat fast and this condition can be life-threatening. An ablation procedure is performed in patients who have VT despite the best treatment available with tablets.
Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by applying a type of electrical energy through a catheter. An important part of the ablation procedure is the identification of the exact part of the heart muscle responsible for causing the VT. This typically involves sampling the electrical signals in lots of different areas of the heart, which allows the construction of computer generated 3 dimensional pictures of the structure and the electrical circuits inside the ventricle. Recent research has identified a new method to interpret these electrical signals (called Fibrillatory Factor - FF), which may allow better identification of the area within the ventricle that should be ablated.
A standard VT ablation will often involve us controlling the heart-beat by pacing the heart through 1 of the investigators catheters within the heart. The electrical response to pacing at different heart rates can often provide your doctor with information to help the ablation. This study will involve an additional period of pacing at different heart rates, during which the electrical response is measured in different areas around the ventricle. This will allow us to calculate areas of the ventricle, which the investigators new measure FF would predict to be the source of the VT. In the future this may then allow us to better identify patients who are at risk of VT, and to better locate the area that needs to be ablated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventricular Tachycardia (VT) | Experimental | Procedure: Fibrillatory Factor calculation (FF)Patients with VT will undergo a clinically indicated ablation of their VT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or above, and capable of giving informed consent
- Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia
Key exclusion criteria (6 listed)
- Moderate or severe aortic stenosis or mitral stenosis
- Active infection
- Presence of thrombus, cardiac tumour, interatrial Baffle patch (a specific form of congenital cardiac surgery) or prior septal occluder device
- Subjects who cannot be anticoagulated of infused with heparinized saline
- A history of heparin induced thrombocytopenia
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 |
|---|---|---|
| Fibrillatory Factor calculation (FF)During sinus rhythm these patients will undergo a simple pacing protocol to allow us to calculate FF, which is an area we would predict is mod likely to be the origin of their VT. | Procedure or surgery | Ventricular Tachycardia (VT) |
Primary outcome
Fibrillatory Factor
Time frame: 18 months
To identify the proportion of clinical VT circuits which could be predicted during sinus rhythm from the calculation of fibrillation factor. The number of FF derived VT exit points which are successfully predicted blindly by the investigators (using the clinically derived VT exit point based on electrophysiology assessment and ablation) will be the primary endpoint.
1 secondary outcome
Real-time fibrillatory factor
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
Related trials for Ventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Jaswinder Gill, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibrillatory Factor calculation (FF) in people with Ventricular Tachycardia, run by Guy's and St Thomas' NHS Foundation Trust at 1 site 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Nov 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaswinder Gill, MD (+44 2071887188, jaswinder.gill@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrillatory Factor (time frame: 18 months). 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 4 Nov 2013; AzTrials last refreshed its copy on 30 Oct 2026.