Fibrillatory Factor in Ventricular Tachycardia
Primary Purpose
Ventricular Tachycardia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fibrillatory Factor calculation (FF)
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Tachycardia focused on measuring Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Age 18 or above, and capable of giving informed consent
- Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia
Exclusion Criteria:
- 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
Sites / Locations
- Guys and St Thomas' NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ventricular Tachycardia (VT)
Arm Description
Patients with VT will undergo a clinically indicated ablation of their VT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01974908
First Posted
July 13, 2013
Last Updated
October 28, 2013
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01974908
Brief Title
Fibrillatory Factor in Ventricular Tachycardia
Official Title
Using Fibrillatory Factor to Predict the Source of Ventricular Tachycardia in Man
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular Tachycardia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ventricular Tachycardia (VT)
Arm Type
Experimental
Arm Description
Patients with VT will undergo a clinically indicated ablation of their VT
Intervention Type
Procedure
Intervention Name(s)
Fibrillatory Factor calculation (FF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fibrillatory Factor
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Real-time fibrillatory factor
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or above, and capable of giving informed consent
Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaswinder Gill, MD
Phone
+44 2071887188
Email
jaswinder.gill@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Child, BM
Phone
+44 2071887188
Email
nick.child@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaswinder Gill, MD
Organizational Affiliation
Guy's and St Thomas' NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guys and St Thomas' NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaswinder Gill, MD
12. IPD Sharing Statement
Learn more about this trial
Fibrillatory Factor in Ventricular Tachycardia
We'll reach out to this number within 24 hrs