We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Catheter Contact Force and Electrograms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Barts & The London NHS Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587404
First Posted: April 30, 2012
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Barts & The London NHS Trust
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation Device: THERMOCOOL® SMARTTOUCH™ Catheter Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Electrogram amplitude [ Time Frame: Baseline and 30 seconds ]
  • 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.

  • 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

  • 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


Estimated Enrollment: 55
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Constant Catheter Contact Force
No alteration of catheter contact force during recording period
Device: THERMOCOOL® SMARTTOUCH™ Catheter
Variable contact force as measured at the catheter tip within the left atrium
Experimental: Variable catheter contact force
change in contact force from low to high after 30seconds of recording.
Device: THERMOCOOL® SMARTTOUCH™ Catheter
Variable contact force as measured at the catheter tip within the left atrium

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587404


Contacts
Contact: Richard J Schilling, MD +4420 3465 5398 Richard.Schilling@bartshealth.nhs.uk

Locations
United Kingdom
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Principal Investigator: Richard J Schilling, MD         
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Principal Investigator: Richard J Schilling, MD Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01587404     History of Changes
Other Study ID Numbers: 007856 BLT
First Submitted: April 23, 2012
First Posted: April 30, 2012
Last Update Posted: August 19, 2015
Last Verified: July 2015

Keywords provided by Barts & The London NHS Trust:
Atrial Fibrillation
Electrogram
Ablation
Contact Force

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes