Atrial FlutterVERISMARTNCT02490033
The VERISMART Trial
A study testing Ablation Catheter in people with Atrial Flutter, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2015to 28 Oct 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Documented paroxysmal or persistent atrial flutter
Who cannot join
- Inability or unwillingness to receive oral anticoagulation
- Previous ablation procedure for AFL
- Unwillingness or inability to complete the required follow up arrangements
- Concomitant atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,
About this study
Official title: Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.
- Conditions
- Atrial Flutter
- Being tested
- Ablation Catheter
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Contact force unblinded | Other | Not described Receives: Device: Ablation Catheter |
| Contact force blinded | Other | Not described Receives: Device: Ablation Catheter |
| ECI unblinded | Other | Not described Receives: Device: Ablation Catheter |
| ECI blinded | Other | Not described Receives: Device: Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve bi-directional block
Time to achieve bi-directional block (secs) . This is defined as the time from the first lesion to the time that consistent (< one minute) bidirectional block is achieved.
Total RF energy required for the whole procedure (sec), and total energy required for ablation (power x ablation time in secs).
Measured: up to 60 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start1 Apr 2015
- Primary completion6 Jan 2017
- Study completion28 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490033
- Sponsor's protocol ID
- CD13/11009
- Other IDs
- 14/YH/0038
- Acronym
- VERISMART
- Status last verified
- Aug 2019
- First submitted
- 18 May 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Begg GA, O'Neill J, Sohaib A, McLean A, Pepper CB, Graham LN, Hogarth AJ, Page SP, Gillott RG, Hill N, Walshaw J, Schilling RJ, Kanagaratnam P, Tayebjee MH. Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial). PLoS One. 2019 Apr 3;14(4):e0212903. doi: 10.1371/journal.pone.0212903. eCollection 2019.
PubMed 30943196
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
- ClinicalTrials.gov ID
- NCT02490033
- Acronym / sponsor ID
- VERISMART / CD13/11009
- Conditions
- Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 1 Apr 2015
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 3 Jul 2015 (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.
Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Contact force unblinded | Other | Device: Ablation Catheter |
| Contact force blinded | Other | Device: Ablation Catheter |
| ECI unblinded | Other | Device: Ablation Catheter |
| ECI blinded | Other | Device: Ablation Catheter |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Documented paroxysmal or persistent atrial flutter
Key exclusion criteria (4 listed)
- Inability or unwillingness to receive oral anticoagulation
- Previous ablation procedure for AFL
- Unwillingness or inability to complete the required follow up arrangements
- Concomitant atrial fibrillation
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 |
|---|---|---|
| Ablation Catheter | Device | Contact force blinded, Contact force unblinded, ECI blinded, ECI unblinded |
Primary outcome
Time to achieve bi-directional block
Time frame: up to 60 Seconds
Time to achieve bi-directional block (secs) . This is defined as the time from the first lesion to the time that consistent (< one minute) bidirectional block is achieved. Total RF energy required for the whole procedure (sec), and total energy required for ablation (power x ablation time in secs).
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 8 Aug 2019.
- Results publication: PubMed 30943196Begg GA, O'Neill J, Sohaib A, McLean A, Pepper CB, Graham LN, Hogarth AJ, Page SP, Gillott RG, Hill N, Walshaw J, Schilling RJ, Kanagaratnam P, Tayebjee MH. Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial). PLoS One. 2019 Apr 3;14(4):e0212903. doi: 10.1371/journal.pone.0212903. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation Catheter in people with Atrial Flutter, run by The Leeds Teaching 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 2 inclusion and 4 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 8 Aug 2019. 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. 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?
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?
Time to achieve bi-directional block (time frame: up to 60 Seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490033, which also lists 1 linked publication.
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 8 Aug 2019.