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NCT Number: NCT01596959

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

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.

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

John Radcliffe Hospital

Headington, Oxfordshire, OX39DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Radiofrequency ablation utilising the ECI contact software

Procedure

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

Other names: Ensite Contact, Electrical Coupling Index

Radiofrequency ablation without the use of ECI contact data

Procedure

irrigated RF ablation without the use of ECI contact data

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 11, 2012
Registry last updated
Oct 13, 2017

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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