The Contact-CTI Study: Use of Tissue Contact Data to Guide Atrial Flutter Ablation
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Radiofrequency ablation utilising the ECI contact software
Radiofrequency ablation without the use of ECI contact data
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring atrial flutter, ablation, irrigation, contact, ECI
Eligibility Criteria
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
Sites / Locations
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ECI CONTACT-ACTIVE
ECI CONTACT-INACTIVE
Arm Description
Irrigated Radiofrequency ablation performed using the ECI contact data
irrigated RF ablation performed to the right atrium without the use of ECI contact data
Outcomes
Primary Outcome Measures
The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block
Secondary Outcome Measures
Full Information
NCT ID
NCT01596959
First Posted
May 9, 2012
Last Updated
October 11, 2017
Sponsor
Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01596959
Brief Title
The Contact-CTI Study: Use of Tissue Contact Data to Guide Atrial Flutter Ablation
Official Title
The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
atrial flutter, ablation, irrigation, contact, ECI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECI CONTACT-ACTIVE
Arm Type
Active Comparator
Arm Description
Irrigated Radiofrequency ablation performed using the ECI contact data
Arm Title
ECI CONTACT-INACTIVE
Arm Type
Placebo Comparator
Arm Description
irrigated RF ablation performed to the right atrium without the use of ECI contact data
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation utilising the ECI contact software
Other Intervention Name(s)
Ensite Contact, Electrical Coupling Index
Intervention Description
irrigated radiofrequency ablation to the right atrium using the ECI contact data
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation without the use of ECI contact data
Intervention Description
irrigated RF ablation without the use of ECI contact data
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Betts, MbChB, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
John Radcliffe Hospital
City
Headington
State/Province
Oxfordshire
ZIP/Postal Code
OX39DU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Contact-CTI Study: Use of Tissue Contact Data to Guide Atrial Flutter Ablation
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