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

NCT ID: NCT01596959

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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

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Atrial Flutter

Keywords

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atrial flutter ablation irrigation contact ECI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ECI CONTACT-ACTIVE

Irrigated Radiofrequency ablation performed using the ECI contact data

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation utilising the ECI contact software

Intervention Type PROCEDURE

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

ECI CONTACT-INACTIVE

irrigated RF ablation performed to the right atrium without the use of ECI contact data

Group Type PLACEBO_COMPARATOR

Radiofrequency ablation without the use of ECI contact data

Intervention Type PROCEDURE

irrigated RF ablation without the use of ECI contact data

Interventions

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Radiofrequency ablation utilising the ECI contact software

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

Intervention Type PROCEDURE

Radiofrequency ablation without the use of ECI contact data

irrigated RF ablation without the use of ECI contact data

Intervention Type PROCEDURE

Other Intervention Names

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Ensite Contact Electrical Coupling Index

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Betts, MbChB, MD

Role: STUDY_DIRECTOR

Oxford University Hospitals NHS Trust

Locations

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John Radcliffe Hospital

Headington, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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11/SC/0394

Identifier Type: OTHER

Identifier Source: secondary_id

79426/244082/1/568

Identifier Type: -

Identifier Source: org_study_id