Atrial Flutter
Conditions
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.
Interventions
DEVICEAblation Catheter
Sponsors
Biosense Webster, Inc.
The Leeds Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United Kingdom
Outcome results
None listed