Clinical trial NCT01587404: Catheter Contact Force and Electrograms
Official title: Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Electrogram
Ablation
Contact Force
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Electrogram characteristics
timeFrame: Baseline and 30 seconds
Secondary outcomes:
measure: Electrogram amplitude
timeFrame: Baseline and 30 seconds
measure: Electrogram responses to ablation
timeFrame: Baseline and 30 seconds
measure: Ablation Power (Watts)
timeFrame: Baseline and 30 seconds
measure: Electrogram Contact Mapping
timeFrame: During Study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University
name: Richard J Schilling, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.