Catheter Contact Force and Electrograms

NCT ID: NCT01587404

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2018-08-21

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Constant Catheter Contact Force

No alteration of catheter contact force during recording period

Group Type: EXPERIMENTAL

THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)

Intervention Type: DEVICE

Variable contact force as measured at the catheter tip within the left atrium

Variable catheter contact force

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

Group Type: EXPERIMENTAL

THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)

Intervention Type: DEVICE

Variable contact force as measured at the catheter tip within the left atrium

Interventions

THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)

Variable contact force as measured at the catheter tip within the left atrium

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard J Schilling, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University

Locations

St Bartholomew's Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26152560 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24443504 (View on PubMed)

Other Identifiers

007856 BLT

Identifier Type: -

Identifier Source: org_study_id