MedTrace Logo

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

NCT01596959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2017-10-13

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Flutter

Interventions

PROCEDURE

Radiofrequency ablation utilising the ECI contact software

irrigated radiofrequency ablation to the right atrium using the ECI contact data

PROCEDURE

Radiofrequency ablation without the use of ECI contact data

irrigated RF ablation without the use of ECI contact data

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Timothy Betts, MbChB, MD · Oxford University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596959 on ClinicalTrials.gov