Atrial FlutterPhase 4NCT01596959
The Contact-CTI Study: Use of Tissue Contact Data to Guide Atrial Flutter Ablation
A Phase 4 study testing Radiofrequency ablation utilising the ECI contact software and Radiofrequency ablation without the use of ECI contact data in people with Atrial Flutter, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Radiofrequency ablation utilising the ECI contact software and Radiofrequency ablation without the use of ECI contact data
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous percutaneous or open surgical procedure involving the right atrium
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Headington, Oxfordshire, OX39DU
About this study
Official title: The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?
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.
Read the 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
- Being tested
- Radiofrequency ablation utilising the ECI contact software, Radiofrequency ablation without the use of ECI contact data
- Keywords
- atrial flutter, ablation, irrigation, contact, ECI
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation utilising the ECI contact softwareProcedure or surgery
Also called Ensite Contact, Electrical Coupling Index
irrigated radiofrequency ablation to the right atrium using the ECI contact data
Radiofrequency ablation without the use of ECI contact dataProcedure or surgery
irrigated RF ablation without the use of ECI contact data
| Study group | Role | What they receive |
|---|---|---|
| ECI CONTACT-ACTIVE | Active comparator | Irrigated Radiofrequency ablation performed using the ECI contact data Receives: Procedure: Radiofrequency ablation utilising the ECI contact software |
| ECI CONTACT-INACTIVE | Placebo comparator | irrigated RF ablation performed to the right atrium without the use of ECI contact data Receives: Procedure: Radiofrequency ablation without the use of ECI contact data |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block
Measured: immediate (intra-procedural)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Betts, MbChB, MD, Study director, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596959
- Sponsor's protocol ID
- 79426/244082/1/568
- Other IDs
- 11/SC/0394
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?
- ClinicalTrials.gov ID
- NCT01596959
- Acronym / sponsor ID
- 79426/244082/1/568
- Conditions
- Atrial Flutter
- Keywords
- atrial flutter, ablation, irrigation, contact, ECI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECI CONTACT-ACTIVE | Active comparator | Procedure: Radiofrequency ablation utilising the ECI contact softwareIrrigated Radiofrequency ablation performed using the ECI contact data |
| ECI CONTACT-INACTIVE | Placebo comparator | Procedure: Radiofrequency ablation without the use of ECI contact datairrigated RF ablation performed to the right atrium without the use of ECI contact data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Previous percutaneous or open surgical procedure involving the right atrium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation utilising the ECI contact softwareAlso: Ensite Contact, Electrical Coupling Indexirrigated radiofrequency ablation to the right atrium using the ECI contact data | Procedure or surgery | ECI CONTACT-ACTIVE |
| Radiofrequency ablation without the use of ECI contact datairrigated RF ablation without the use of ECI contact data | Procedure or surgery | ECI CONTACT-INACTIVE |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Betts, MbChB, MD study director
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiofrequency ablation utilising the ECI contact software and Radiofrequency ablation without the use of ECI contact data in people with Atrial Flutter, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.