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Clinical Trials/NCT02490033
NCT02490033
Completed
Not Applicable

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

The Leeds Teaching Hospitals NHS Trust1 site in 1 country133 target enrollmentApril 1, 2015
ConditionsAtrial Flutter

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Flutter
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrollment
133
Locations
1
Primary Endpoint
Time to achieve bi-directional block
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2015
End Date
October 28, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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).

Study Sites (1)

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