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

This study is currently recruiting participants.
Verified May 2012 by Oxford University Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Dr Michael Jones, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01596959
First received: May 9, 2012
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Flutter
 Procedure: Radiofrequency ablation utilising the ECI contact software
Procedure: Radiofrequency ablation without the use of ECI contact data
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?

Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ECI CONTACT-ACTIVE
Irrigated Radiofrequency ablation performed using the ECI contact data
 Procedure: Radiofrequency ablation utilising the ECI contact software
irrigated radiofrequency ablation to the right atrium using the ECI contact data
Other Names:
  • Ensite Contact
  • Electrical Coupling Index
Placebo Comparator: ECI CONTACT-INACTIVE
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
irrigated RF ablation without the use of ECI contact data

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596959

Contacts
Contact: michael a jones, MBBS +441865740406 ext 740406 michael.jones@orh.nhs.uk
Contact: tim betts, MBCHB PhD +440865220256 ext 220256 tim.betts@orh.nhs.uk

Locations
United Kingdom
John Radcliffe Hospital Recruiting
Headington, Oxfordshire, United Kingdom, OX39DU
Contact: tim betts, MbChb PHd     +441865220256 ext 220256     tim.betts@orh.nhs.uk    
Principal Investigator: michael a jones, MBBS            
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Study Director: Timothy Betts, MbChB, MD Oxford University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Dr Michael Jones, Electrophysiology Research fellow, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01596959     History of Changes
Other Study ID Numbers: 79426/244082/1/568, 11/SC/0394
Study First Received: May 9, 2012
Last Updated: May 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Oxford University Hospitals NHS Trust:
atrial flutter
ablation
irrigation
contact
ECI

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013