The VERISMART Trial

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.

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3HE,, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablation Catheter

Device

Primary outcomes

Time to achieve bi-directional block

Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Collaborators

Biosense Webster, Inc.

Registry information

Official study title

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

Acronym: VERISMART

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Jul 3, 2015
Registry last updated: Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed