Atrial FlutterNCT02825498
Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
A study testing Contact force guided RFA in people with Atrial Flutter and Radiofrequency Catheter Ablation, run by Victoria Cardiac Arrhythmia Trials at 1 site in Canada.
Trial summary
Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Flutter, Radiofrequency Catheter Ablation
- What is being tested?
- Contact force guided RFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 18 May 2016to Dec 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
- Able and willing to give informed consent.
Who cannot join
- Previous CTI ablation
- Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
Trial locations and contacts
1 site in 1 country.
About this study
Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.
Read the detailed description
Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.
- Conditions
- Atrial Flutter, Radiofrequency Catheter Ablation
- Being tested
- Contact force guided RFA
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact force guided RFADevice
Contact force guided RFA during Atrial Flutter ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Operator guided by contact force | Experimental | Operator has full access to contact force parameters including force time integral (FTI). Receives: Device: Contact force guided RFA |
| Operator blinded to contact force | No intervention | Operator is blinded to contact force with ablation guided by standard markers of effective ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of RFA
Total RFA time required to achieve bidirectional block
Measured: Determined during RFA procedure
Secondary outcomes (13)
Recurrence of atrial flutter
Documented recurrence of atrial flutter
Measured: Assessed at 12 weeks and 12 months post CTI RFA procedure
Average total CF achieved
Average total CF per ablation per segment (third) of the CTI.
Measured: Determined during RFA procedure
Average axial CF achieved
Average axial CF per ablation per segment (third) of the CTI.
Measured: Determined during RFA procedure
Average FTI achieved
Average FTI per ablation per segment (third) of the CTI.
Measured: Determined during RFA procedure
Average lateral CF achieved
Average lateral CF per ablation per segment (third) of the CTI.
Measured: Determined during RFA procedure
Average lesion size index (LSI) achieved
Average lesion size index (LSI) per ablation per segment (third) of the CTI.
Measured: Determined during RFA procedure
Procedural complication rate
Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.
Measured: Determined during RFA procedure and at 12 weeks post RFA procedure
Average total CF of segment of acute and delayed reconnection
Average total CF per ablation in segment (third) of acute or delayed reconnection.
Measured: Determined during index and repeat RFA procedure
Average lateral CF of segment of acute and delayed reconnection
Average lateral CF per ablation in segment (third) of acute or delayed reconnection.
Measured: Determined during index and repeat RFA procedure
Average axial CF of segment of acute and delayed reconnection
Average axial CF per ablation in segment (third) of acute or delayed reconnection.
Measured: Determined during index and repeat RFA procedure
Average FTI of segment of acute and delayed reconnection
Average FTI per ablation in segment (third) of acute or delayed reconnection.
Measured: Determined during index and repeat RFA procedure
Average lesion size index (LSI) of segment of acute and delayed reconnection
Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection.
Measured: Determined during index and repeat RFA procedure
Procedural efficacy of RFA
Total procedural time required to achieve bidirectional block
Measured: Determined during RFA procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start18 May 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victoria Cardiac Arrhythmia Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Novak, MD, Principal investigator, Victoria Cardiac Arrhythmia Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825498
- Sponsor's protocol ID
- C2016-012
- Status last verified
- May 2020
- First submitted
- 4 Jul 2016
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: De-identified IPD may be shared with other researchers upon study completion. Data may be obtained by contacting Victoria Cardiac Arrhythmia Trials Inc. at 250-595-0400.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
- ClinicalTrials.gov ID
- NCT02825498
- Acronym / sponsor ID
- C2016-012
- Conditions
- Atrial Flutter, Radiofrequency Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Victoria Cardiac Arrhythmia TrialsUniversity, hospital or other
- Study start
- 18 May 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Jul 2016 (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.
Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.
Detailed description
Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operator guided by contact force | Experimental | Device: Contact force guided RFAOperator has full access to contact force parameters including force time integral (FTI). |
| Operator blinded to contact force | No intervention | –Operator is blinded to contact force with ablation guided by standard markers of effective ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
- Able and willing to give informed consent.
Key exclusion criteria (2 listed)
- Previous CTI ablation
- Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
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 |
|---|---|---|
| Contact force guided RFAContact force guided RFA during Atrial Flutter ablation procedure. | Device | Operator guided by contact force |
Primary outcome
Efficacy of RFA
Time frame: Determined during RFA procedure
Total RFA time required to achieve bidirectional block
13 secondary outcomes
Recurrence of atrial flutter
Time frame: Assessed at 12 weeks and 12 months post CTI RFA procedure
Average total CF achieved
Time frame: Determined during RFA procedure
Average axial CF achieved
Time frame: Determined during RFA procedure
Average FTI achieved
Time frame: Determined during RFA procedure
Average lateral CF achieved
Time frame: Determined during RFA procedure
Average lesion size index (LSI) achieved
Time frame: Determined during RFA procedure
Procedural complication rate
Time frame: Determined during RFA procedure and at 12 weeks post RFA procedure
Average total CF of segment of acute and delayed reconnection
Time frame: Determined during index and repeat RFA procedure
Average lateral CF of segment of acute and delayed reconnection
Time frame: Determined during index and repeat RFA procedure
Average axial CF of segment of acute and delayed reconnection
Time frame: Determined during index and repeat RFA procedure
Average FTI of segment of acute and delayed reconnection
Time frame: Determined during index and repeat RFA procedure
Average lesion size index (LSI) of segment of acute and delayed reconnection
Time frame: Determined during index and repeat RFA procedure
Procedural efficacy of RFA
Time frame: Determined during RFA procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: Undecided. De-identified IPD may be shared with other researchers upon study completion. Data may be obtained by contacting Victoria Cardiac Arrhythmia Trials Inc. at 250-595-0400.
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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.
Paul Novak, MD principal investigator
Victoria Cardiac Arrhythmia Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact force guided RFA in people with Atrial Flutter and Radiofrequency Catheter Ablation, run by Victoria Cardiac Arrhythmia Trials at 1 site in Canada.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 May 2020. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy of RFA (time frame: Determined during RFA procedure). 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 20 May 2020.