Catheter Contact Force and Electrograms

September 26, 2019 updated by: Barts & The London NHS Trust

Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium

Until recently, there was no way of telling how firmly the tip of the catheter was in contact with the heart and how this contact was orientated. The electrical signals measured through the catheters, known as electrograms, are used to guide the sites and duration of ablation, but the effect of catheter contact and orientation on these signals in human heart muscle that is fibrillating is not known. New catheters have now been developed which can measure the force of contact at their tip: using these, the investigators will examine how contact force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. The effect the force of contact has on the electrogram recorded will also be investigated. In so doing we hope to gain a better understanding of the relationship between tissue contact and the electrograms we measure and in so doing improve the safety and effectiveness of ablation procedures.

Hypothesis: Catheter contact force and orientation have a significant impact on the characteristics of bipolar electrograms in the fibrillating human atrium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persistent or paroxysmal atrial fibrillation
  • Listed for ablation of atrial fibrillation on clinical grounds

Exclusion Criteria:

  • Contraindication to catheter ablation
  • Contraindication to anticoagulation
  • Contraindication to TOE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constant Catheter Contact Force
No alteration of catheter contact force during recording period
Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
Variable contact force as measured at the catheter tip within the left atrium
Experimental: Variable catheter contact force
change in contact force from low to high after 30seconds of recording.
Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
Variable contact force as measured at the catheter tip within the left atrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrogram characteristics
Time Frame: Baseline and 30 seconds
Effect of changes in contact force and orientation on: slew rate, local mean cycle length, electrogram complexity and fractionation index, dominant frequency, organisation index, CFAE grade, interval confidence level, shortest complex interval and average complex interval
Baseline and 30 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrogram amplitude
Time Frame: Baseline and 30 seconds
Baseline and 30 seconds
Electrogram responses to ablation
Time Frame: Baseline and 30 seconds
Slew rate, local mean cycle length, electrogram complexity and fractionation index, dominant frequency, organisation index, CFAE grade, interval confidence level, shortest complex interval and average complex interval, amplitude change, AF cycle length, catheter impedance.
Baseline and 30 seconds
Ablation Power (Watts)
Time Frame: Baseline and 30 seconds
The interaction between catheter contact force and orientation and the power attained during power limited ablation
Baseline and 30 seconds
Electrogram Contact Mapping
Time Frame: During Study
Use of contact catheters - Constellation and/or PentaRay Catheter to record fibrillatory electrograms and identify areas of interest
During Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Investigators

  • Principal Investigator: Richard J Schilling, MD, Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

August 21, 2018

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 007856 BLT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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