Systems and method or uses of ablating cardiac tissue

Use of a multi-electrode radiofrequency balloon catheter for administering a procedure to treat atrial fibrillation, comprising:

• delivering the multi-electrode radiofrequency balloon catheter to one or more targeted pulmonary veins;
• ablating tissue of the pulmonary vein using the multi-electrode radiofrequency balloon catheter at a maximum temperature setting being approximately about 55° C.;
• and
• achieving a predetermined effectiveness rate of pulmonary vein isolation, the predetermined effectiveness rate being defined by determining incidence of complication rates being 10% or less of post-ablation symptomatic and asymptomatic cerebral emboli as compared to pre-ablation.

Use of a multi-electrode radiofrequency balloon catheter to treat a plurality of patients for paroxysmal atrial fibrillation, comprising:

• evaluating a number and size of all targeted pulmonary veins and anatomy of the left atrial;
• puncturing the transseptal;
• selectively positioning a multi-electrode esophageal temperature monitoring device in the vasculature with respect to all targeted pulmonary veins;
• selectively positioning the multi-electrode radiofrequency balloon catheter in the vasculature with respect to all targeted pulmonary veins, the multi-electrode radiofrequency balloon catheter having a plurality of electrodes for radiofrequency ablation;
• selectively positioning a multi-electrode diagnostic catheter in the vasculature with respect to all targeted pulmonary veins;
• ablating tissue of all targeted pulmonary veins with one or more of the plurality of the electrodes independently controlled multi-electrode radiofrequency balloon catheter;
• confirming isolation of all targeted pulmonary veins using the multi-electrode diagnostic catheter;
• confirming existence of an entrance block in all targeted pulmonary veins;
• and
• achieving a predetermined clinical at least approximately a 60% success rate for the plurality of patients being at least approximately 100 patients, based on the confirmed existence of the entrance block, regarding the isolation of all targeted pulmonary veins following the method or use.

A clinically effective device to treat atrial fibrillation in a group of patients, the device comprising an end probe coupled to a tubular member that extends along a longitudinal axis from a proximal portion to a distal portion, the end probe comprising:

• a first expandable membrane coupled to the tubular member;
• a plurality of electrodes disposed generally equiangularly about the longitudinal axis on an outer surface of the first expandable membrane;
• at least one wire connected each of the plurality of electrodes, the at least one wire of each electrode extending from the first expandable membrane toward the tubular member;
• and
• a second expandable membrane that encapsulates a portion of the at least one wire between the second expandable membrane and the first expandable membrane;
• wherein the device is configured to achieve a predetermined effectiveness rate of pulmonary vein isolation in the group of patients, and
• wherein acute effectiveness is defined by confirming if there is an entrance block in all targeted pulmonary veins after adenosine and/or isoproterenol challenge, the acute effectiveness being defined by success greater than approximately 80% for the plurality of patients.

A clinically effective device to administer a procedure for cardiac electrophysiological ablation of pulmonary veins of the atria and treatment of drug refractory recurrent symptomatic pulmonary atrial fibrillation, the device comprising:

• an end probe coupled to a tubular member that extends along a longitudinal axis from a proximal portion to a distal portion, the end probe comprising:
• a first expandable membrane coupled to the tubular member;
• a plurality of electrodes disposed generally equiangularly about the longitudinal axis on an outer surface of the first expandable membrane;
• at least one wire connected each of the plurality of electrodes, the at least one wire of each electrode extending from the first expandable membrane toward the tubular member;
• and
• a second expandable membrane that encapsulates a portion of the at least one wire between the second expandable membrane and the first expandable membrane so that each of the plurality of electrodes is independently controlled to achieve a predetermined effectiveness rate of pulmonary vein isolation,
• wherein acute effectiveness is defined by confirming if there is an entrance block in all targeted pulmonary veins after adenosine and/or isoproterenol challenge, the acute effectiveness being defined by success greater than approximately 80% for the plurality of patients.

A clinically effective device to administer a procedure for cardiac electrophysiological ablation of pulmonary veins of the atria and treatment of drug refractory recurrent symptomatic pulmonary atrial fibrillation, the device comprising:

• an end probe coupled to a tubular member that extends along a longitudinal axis from a proximal portion to a distal portion, the end probe comprising:
• a first expandable membrane coupled to the tubular member;
• a plurality of electrodes disposed generally equiangularly about the longitudinal axis on an outer surface of the first expandable membrane;
• at least one wire connected each of the plurality of electrodes, the at least one wire of each electrode extending from the first expandable membrane toward the tubular member;
• and
• a second expandable membrane that encapsulates a portion of the at least one wire between the second expandable membrane and the first expandable membrane so that each of the plurality of electrodes is independently controlled to achieve pulmonary vein isolation and at least a 97% safety endpoint within seven (7) days of successful pulmonary vein isolation.

A clinically effective device to administer a procedure for cardiac electrophysiological ablation of pulmonary veins of the atria and treatment of drug refractory recurrent symptomatic pulmonary atrial fibrillation, the device comprising:

• an end probe coupled to a tubular member that extends along a longitudinal axis from a proximal portion to a distal portion, the end probe comprising:
• a first expandable membrane coupled to the tubular member;
• a plurality of electrodes disposed generally equiangularly about the longitudinal axis on an outer surface of the first expandable membrane;
• at least one wire connected each of the plurality of electrodes, the at least one wire of each electrode extending from the first expandable membrane toward the tubular member;
• and
• a second expandable membrane that encapsulates a portion of the at least one wire between the second expandable membrane and the first expandable membrane so that each of the plurality of electrodes is independently controlled to achieve pulmonary vein isolation and at least a 60% success rate for a plurality of patients being at least approximately 100 patients, based on the confirmed existence of the entrance block, regarding the isolation of all targeted pulmonary veins following the procedure.