Fibrillatory Factor in Ventricular Tachycardia

NCT01974908 | Unknown

• 1 other identifier: GSTT-FF-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Keywords

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (1)

• Real-time fibrillatory factor

  18 months

Study Arms (1)

Ventricular Tachycardia (VT)

EXPERIMENTAL

Patients with VT will undergo a clinically indicated ablation of their VT

Procedure: Fibrillatory Factor calculation (FF)

Interventions

Fibrillatory Factor calculation (FF) PROCEDURE

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.

Ventricular Tachycardia (VT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above, and capable of giving informed consent
• Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas' NHS Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaswinder Gill, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaswinder Gill, MD

CONTACT

+44 2071887188; jaswinder.gill@gstt.nhs.uk

Nicholas Child, BM

CONTACT

+44 2071887188; nick.child@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Electrophysiologist and Professor of Cardiology

Study Record Dates

• First Submitted: July 13, 2013
• First Posted: November 4, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Last Updated: November 4, 2013

Record last verified: 2013-10

Locations

GB (1)