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

NCT01596959 | Completed Phase 4

• 2 other identifiers: 79426/244082/1/56811/SC/0394
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atrial flutter; ablation; irrigation; contact; ECI

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block

  immediate (intra-procedural)

Study Arms (2)

ECI CONTACT-ACTIVE

ACTIVE COMPARATOR

Irrigated Radiofrequency ablation performed using the ECI contact data

Procedure: Radiofrequency ablation utilising the ECI contact software

ECI CONTACT-INACTIVE

PLACEBO COMPARATOR

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

Interventions

Radiofrequency ablation utilising the ECI contact software PROCEDURE

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

Also known as: Ensite Contact, Electrical Coupling Index

ECI CONTACT-ACTIVE

Radiofrequency ablation without the use of ECI contact data PROCEDURE

irrigated RF ablation without the use of ECI contact data

ECI CONTACT-INACTIVE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

John Radcliffe Hospital

Headington, Oxfordshire, OX39DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Timothy Betts, MbChB, MD

  Oxford University Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 13, 2017

Record last verified: 2012-05

Locations

GB (1)