Catheter Contact Force and Electrograms

Barts & The London NHS Trust

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)

Study type: Interventional

Funder types: Other

Identifiers

NCT01587404

007856 BLT

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Constant Catheter Contact Force

Experimental group

Description:

No alteration of catheter contact force during recording period

Treatment:

Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)

Variable catheter contact force

Experimental group

Description:

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

Treatment:

Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)