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CompletedNCT02490033VERISMARTUpdated Aug 8, 2019

The VERISMART Trial

An interventional study of Ablation Catheter in Atrial Flutter, sponsored by The Leeds Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Atrial Flutter

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03

In context

Atrial Flutter

219 studies on the registry are indexed under Atrial Flutter; 50 are open to participants now.

This study's enrollment of 133 is close to the median of 139 across 148 interventional studies indexed under Atrial Flutter.

Browse Atrial Flutter studies →

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 100 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Documented paroxysmal or persistent atrial flutter

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
133 participants (actual)

Study arms

  • Other
    Contact force unblinded

    Device: Ablation Catheter

  • Other
    Contact force blinded

    Device: Ablation Catheter

  • Other
    ECI unblinded

    Device: Ablation Catheter

  • Other
    ECI blinded

    Device: Ablation Catheter

Interventions

  • DeviceAblation Catheter
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What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 60 Seconds

07

Study locations

1 site
  • Leeds Teaching Hospitals NHS Trust
    Leeds, LS1 3HE,, United Kingdom
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02490033
Responsible party
Sponsor
First posted
Jul 3, 2015
Start date
Apr 1, 2015
Primary completion
Jan 6, 2017
Completion
Oct 28, 2018
Last update
Aug 8, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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