Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17567
Study information
Scientific title
Randomised trial comparing conventional versus contact force and electrical coupling index in atrial flutter ablation (VERISMART TRIAL)
Acronym
VERISMART TRIAL
Study hypothesis
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 known 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.
Ethics approval
14/YH/0038
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Arrhythmia
Intervention
CF versus ECI in CTI flutter
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measures
Time to bidirectional block
Secondary outcome measures
N/A
Overall trial start date
01/02/2015
Overall trial end date
01/02/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age =18 years
2. Documented paroxysmal or persistent atrial flutter
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant exclusion criteria
1. Inability or unwillingness to receive oral anticoagulation
2. Previous ablation procedure for AFL
3. Unwillingness or inability to complete the required follow up arrangements
4. Concomitant atrial fibrillation
Recruitment start date
01/02/2015
Recruitment end date
01/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Funders
Funder type
Government
Funder name
Biosense Webster Inc (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary