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Catheter Contact Force and Electrograms

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Electrogram, Ablation, Contact Force

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Bartholomew's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Constant Catheter Contact Force

Variable catheter contact force

Arm Description

No alteration of catheter contact force during recording period

change in contact force from low to high after 30seconds of recording.

Outcomes

Primary Outcome Measures

Electrogram characteristics
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

Secondary Outcome Measures

Electrogram amplitude
Electrogram responses to ablation
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.
Ablation Power (Watts)
The interaction between catheter contact force and orientation and the power attained during power limited ablation
Electrogram Contact Mapping
Use of contact catheters - Constellation and/or PentaRay Catheter to record fibrillatory electrograms and identify areas of interest

Full Information

First Posted
April 23, 2012
Last Updated
September 26, 2019
Sponsor
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01587404
Brief Title
Catheter Contact Force and Electrograms
Official Title
Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Electrogram, Ablation, Contact Force

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Constant Catheter Contact Force
Arm Type
Experimental
Arm Description
No alteration of catheter contact force during recording period
Arm Title
Variable catheter contact force
Arm Type
Experimental
Arm Description
change in contact force from low to high after 30seconds of recording.
Intervention Type
Device
Intervention Name(s)
THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
Intervention Description
Variable contact force as measured at the catheter tip within the left atrium
Primary Outcome Measure Information:
Title
Electrogram characteristics
Description
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
Time Frame
Baseline and 30 seconds
Secondary Outcome Measure Information:
Title
Electrogram amplitude
Time Frame
Baseline and 30 seconds
Title
Electrogram responses to ablation
Description
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.
Time Frame
Baseline and 30 seconds
Title
Ablation Power (Watts)
Description
The interaction between catheter contact force and orientation and the power attained during power limited ablation
Time Frame
Baseline and 30 seconds
Title
Electrogram Contact Mapping
Description
Use of contact catheters - Constellation and/or PentaRay Catheter to record fibrillatory electrograms and identify areas of interest
Time Frame
During Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Schilling, MD
Organizational Affiliation
Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26152560
Citation
Ullah W, Hunter RJ, Baker V, Ling LH, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Impact of Catheter Contact Force on Human Left Atrial Electrogram Characteristics in Sinus Rhythm and Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1030-9. doi: 10.1161/CIRCEP.114.002483. Epub 2015 Jul 7.
Results Reference
derived
PubMed Identifier
24443504
Citation
Ullah W, Hunter RJ, Baker V, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Target indices for clinical ablation in atrial fibrillation: insights from contact force, electrogram, and biophysical parameter analysis. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):63-8. doi: 10.1161/CIRCEP.113.001137. Epub 2014 Jan 18.
Results Reference
derived

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Catheter Contact Force and Electrograms

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