Cardima Receives Approval for AF Treatment Study

Cardima, developer of the INTELLITEMP and REVELATION series of cardiac interventional systems for the treatment of atrial fibrillation (AF), received approval from the regional ethic's committee at Guy's and St. Thomas Hospitals located in London to conduct a clinical study using the REVELATION T-Flex and REVELATION Helix catheters with the INTELLITEMP in the left atrium to create line of block lesions for the treatment of AF.

The single-arm, nonrandomized study is expected to involve 30 subjects from Guy's and St. Thomas Hospitals. The study will examine the clinical effect of creating line of block lesions with radiofrequency energy in the left atrium and pulmonary veins of the heart on patients suffering from AF, using the Cardima REVELATION T-Flex and REVELATION Helix catheter with the INTELLITEMP devices.

Under the approved trial design the study will additionally evaluate the rate of recurrence and the rate of symptomatic AF episodes in these patients after treatment through six months following treatment. Secondary objectives of the study will evaluate the length of procedure times, assessment of other procedural measurements such as the line of block placement and completeness of the line of block, and incidence of any device or procedural adverse effects.