Comparing conventional verses contact force and electrical coupling index in atrial flutter ablation

ISRCTN	ISRCTN72708537
DOI	https://doi.org/10.1186/ISRCTN72708537
Secondary identifying numbers	17567

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Muzahir Tayebjee
Scientific

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

Study design	Randomised; Interventional
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Randomised trial comparing conventional versus contact force and electrical coupling index in atrial flutter ablation (VERISMART TRIAL)
Study acronym	VERISMART TRIAL
Study objectives	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(s)	14/YH/0038
Health condition(s) or problem(s) studied	Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Arrhythmia
Intervention	CF versus ECI in CTI flutter
Intervention type	Other
Primary outcome measure	Time to bidirectional block
Secondary outcome measures	N/A
Overall study start date	01/02/2015
Completion date	01/02/2017

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 120; UK Sample Size: 120
Total final enrolment	114
Key inclusion criteria	1. Age =18 years 2. Documented paroxysmal or persistent atrial flutter
Key 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
Date of first enrolment	01/02/2015
Date of final enrolment	01/02/2017

Leeds General Infirmary

Great George Street
Leeds
LS1 3EX
United Kingdom

Leeds Teaching Hospitals NHS Trust
Hospital/treatment centre

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

"ROR"	https://ror.org/00v4dac24

Government

Biosense Webster Inc (USA)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	03/04/2019	10/05/2021	Yes	No
Protocol (other)		09/02/2023	No	No
HRA research summary		28/06/2023	No	No

09/02/2023: Protocol added.
10/05/2021: Publication reference and total final enrolment number added.