The VERISMART Trial

Atrial Flutter Clinical Trial

— VERISMART  

Official title:

Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490033
• Other study ID #: CD13/11009
• Secondary ID: 14/YH/0038
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: October 28, 2018

Study information

• Verified date: August 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 28, 2018
• Est. primary completion date: January 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age =18 years

• Documented paroxysmal or persistent atrial flutter

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• Ablation Catheter

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust	Biosense Webster, Inc.

Country where clinical trial is conducted

United Kingdom, 

References & 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 flut — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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