Condition category
Circulatory System
Date applied
14/01/2015
Date assigned
15/01/2015
Last edited
29/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muzahir Tayebjee

ORCID ID

Contact details

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

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

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust

Sponsor details

Research & Development
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes