Catheter Contact Force and Electrograms

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587404
• Other study ID #: 007856 BLT
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: August 21, 2018

Study information

• Verified date: September 2019
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 21, 2018
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
Variable contact force as measured at the catheter tip within the left atrium

Locations

Country	Name	City	State
United Kingdom	St Bartholomew's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 30 seconds
Secondary	Electrogram amplitude		Baseline and 30 seconds
Secondary	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.	Baseline and 30 seconds
Secondary	Ablation Power (Watts)	The interaction between catheter contact force and orientation and the power attained during power limited ablation	Baseline and 30 seconds
Secondary	Electrogram Contact Mapping	Use of contact catheters - Constellation and/or PentaRay Catheter to record fibrillatory electrograms and identify areas of interest	During Study