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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596959
First Posted: May 11, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oxford University Hospitals NHS Trust
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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) ]

Enrollment: 101
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596959


Locations
United Kingdom
John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom, OX39DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Study Director: Timothy Betts, MbChB, MD Oxford University Hospitals NHS Trust
  More Information

Responsible Party: Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01596959     History of Changes
Other Study ID Numbers: 79426/244082/1/568
11/SC/0394 ( Other Identifier: NRES Oxford C south central )
First Submitted: May 9, 2012
First Posted: May 11, 2012
Last Update Posted: October 13, 2017
Last Verified: May 2012

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