Comparing conventional verses contact force and electrical coupling index in atrial flutter ablation
| ISRCTN | ISRCTN72708537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72708537 |
| Protocol serial number | 17567 |
| Sponsor | Leeds Teaching Hospitals NHS Trust |
| Funder | Biosense Webster Inc (USA) |
- Submission date
- 14/01/2015
- Registration date
- 15/01/2015
- Last edited
- 09/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Muzahir Tayebjee
Scientific
Scientific
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Time to bidirectional block |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 01/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Leeds
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/04/2019 | 10/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol (other) | 09/02/2023 | No | No |
Editorial Notes
09/02/2023: Protocol added.
10/05/2021: Publication reference and total final enrolment number added.
