The VERISMART Trial
VERISMART
Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
2 other identifiers
interventional
133
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2018
CompletedAugust 8, 2019
August 1, 2019
1.8 years
May 18, 2015
August 6, 2019
Conditions
Outcome Measures
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).
up to 60 Seconds
Study Arms (4)
Contact force unblinded
OTHERContact force blinded
OTHERECI unblinded
OTHERECI blinded
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Documented paroxysmal or persistent atrial flutter
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Leeds Teaching Hospitals NHS Trustlead
- Biosense Webster, Inc.collaborator
Study Sites (1)
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,, United Kingdom
Related Publications (1)
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.
PMID: 30943196RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
July 3, 2015
Study Start
April 1, 2015
Primary Completion
January 6, 2017
Study Completion
October 28, 2018
Last Updated
August 8, 2019
Record last verified: 2019-08