The VERISMART Trial

The Leeds Teaching Hospitals NHS Trust

Status: Completed

Conditions: Atrial Flutter

Treatments: Device: Ablation Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02490033

14/YH/0038 (Other Identifier)

CD13/11009

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 4 patient groups

Contact force unblinded

Other group

Treatment:

Device: Ablation Catheter

Contact force blinded

Other group

Treatment:

Device: Ablation Catheter

ECI unblinded

Other group

Treatment:

Device: Ablation Catheter

ECI blinded

Other group

Treatment:

Device: Ablation Catheter