The VERISMART Trial

Not Applicable

Completed

• Conditions: Atrial Flutter
• Interventions: Device: Ablation Catheter

• Registration Number: NCT02490033
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-03
• Primary Completion: 2017-01-06
• Study Completion: 2018-10-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact force blinded	Ablation Catheter	-
ECI unblinded	Ablation Catheter	-
ECI blinded	Ablation Catheter	-
Contact force unblinded	Ablation Catheter	-

Primary Outcome Measures

Name	Time	Method
Time to achieve bi-directional block	up to 60 Seconds	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).

Trial Locations

Locations (1)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom