The Contact-CTI Study: Use of Tissue Contact Data to Guide Atrial Flutter Ablation

October 11, 2017 updated by: Oxford University Hospitals NHS Trust

The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?

This study will be a single blind prospective randomised control trial in patients undergoing ablation for the treatment of typical atrial flutter, with the aim of investigating the benefit of a new impedance-based computer software application which measures tissue contact between the ablation catheter and the inside of the heart.

The investigators hope to demonstrate that the use of this tissue contact information reduces ablation time, Xray time, and procedure time required to complete the procedure successfully. Study participants will be randomly assigned to undergo their procedure with or without this contact data displayed for the doctor performing the ablation to see. The acute procedural endpoint of ablation is successful conduction block across the cavotricuspid isthmus of the right atrium. If the outcome of this study is positive, it will have a significant beneficial impact on this procedure, reducing procedure length, patient discomfort, and potentially reducing risk for the patient, recurrent arrythmia symptoms, and the need for repeat procedures later on.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients in this study will be de novo cases of atrial flutter ablation, and they will be randomised to ablation using tissue contact data provided by the St. Jude medical ECI technology (active arm), or standard ablation as per physician practice, without the use of contact data to guide ablation (control arm). The endpoint measures will include RF ablation time, procedure time, time to achieving cavotricuspid isthmus block, the need for "touch up" ablation to achieve conduction block, the recurrence rate of isthmus conduction on isuprel infusion at 20 minutes post-isolation, and clinical recurrence of atrial flutter post-operatively.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Headington, Oxfordshire, United Kingdom, OX39DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is undergoing de novo cavotricuspid isthmus ablation.
  2. Participant is willing and able to give informed consent for participation in the study.
  3. Male or Female, aged 18 years or over

Exclusion Criteria:

(1) Previous percutaneous or open surgical procedure involving the right atrium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ECI CONTACT-ACTIVE
Irrigated Radiofrequency ablation performed using the ECI contact data
Procedure: Radiofrequency ablation utilising the ECI contact software
irrigated radiofrequency ablation to the right atrium using the ECI contact data
Other Names:
  • Ensite Contact
  • Electrical Coupling Index
Placebo Comparator: ECI CONTACT-INACTIVE
irrigated RF ablation performed to the right atrium without the use of ECI contact data
Procedure: Radiofrequency ablation without the use of ECI contact data
irrigated RF ablation without the use of ECI contact data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block
Time Frame: immediate (intra-procedural)
immediate (intra-procedural)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Investigators

  • Study Director: Timothy Betts, MbChB, MD, Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 79426/244082/1/568
  • 11/SC/0394 (Other Identifier: NRES Oxford C south central)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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