NCT01596959

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Oxford University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Atrial Flutter

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-05-11
• Last updated: 2017-10-13

Locations

1 site across 1 country: United Kingdom