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Completed

NCT Number: NCT01587404

Catheter Contact Force and Electrograms

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)

Device

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

Primary outcomes

  1. Electrogram characteristics

    Time frame: Baseline and 30 seconds

    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 outcomes

  1. Electrogram amplitude

    Time frame: Baseline and 30 seconds

  2. Electrogram responses to ablation

    Time frame: Baseline and 30 seconds

    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.

  3. Ablation Power (Watts)

    Time frame: Baseline and 30 seconds

    The interaction between catheter contact force and orientation and the power attained during power limited ablation

  4. Electrogram Contact Mapping

    Time frame: During Study

    Use of contact catheters - Constellation and/or PentaRay Catheter to record fibrillatory electrograms and identify areas of interest

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Apr 30, 2012
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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