Systems and method or uses of ablating cardiac tissue

Abstract

The subject of this disclosure is devices, systems, and uses thereof to treat a plurality of patients for paroxysmal atrial fibrillation. The solution can include delivering a multi-electrode radiofrequency balloon catheter and a multi-electrode diagnostic catheter to one or more targeted pulmonary veins; ablating tissue of the one or more targeted pulmonary veins using the multi-electrode radiofrequency balloon catheter; diagnosing the one or more targeted pulmonary veins using the multi-electrode diagnostic catheter; and achieving at least one of a predetermined clinical effectiveness and acute effectiveness of the method or use based on use of the multi-electrode radiofrequency balloon catheter and the multi-electrode diagnostic catheter in the isolation of the one or more targeted pulmonary veins.

What is claimed is: 
     
         1 . 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 group of patients.   
     
     
         2 . The device of  claim 1 , wherein the predetermined effectiveness rate includes complication rates of 10% or less and is defined by existence or non-existence of asymptomatic cerebral embolic lesions at a discharge magnetic resonance imaging (MRI). 
     
     
         3 . The device of  claim 1 , wherein the predetermined effectiveness rate includes complication rates of approximately 0% and is defined by existence or non-existence of esophageal injury erythema. 
     
     
         4 . The device of  claim 1 , wherein the predetermined effectiveness rate is approximately 100% and is defined by electrically isolating all targeted pulmonary veins without use of a focal ablation catheter. 
     
     
         5 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by a freedom from documented atrial fibrillation, atrial tachycardia, or atypical atrial flutter episodes based on electrocardiographic data through an effectiveness evaluation period. 
     
     
         6 . The device of  claim 5 , wherein the effectiveness evaluation period is approximately one year. 
     
     
         7 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by pulmonary vein isolation touch-up by a focal catheter among all targeted pulmonary veins. 
     
     
         8 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by using focal catheter ablation for non-PV triggers during an index procedure. 
     
     
         9 . The device of  claim 1 , wherein the predetermined effectiveness rate comprises a long-term effectiveness rate. 
     
     
         110 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by an average number of Radio-Frequency applications per patient and Radio-Frequency time required to isolate all pulmonary veins. 
     
     
         11 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by an average number of Radio-Frequency applications per vein and Radio-Frequency time required to isolate common pulmonary veins. 
     
     
         12 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by an average number of Radio-Frequency applications per patient and Radio-Frequency time required to isolate common pulmonary veins. 
     
     
         13 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by determining incidence of complication rates being 10% or less of post-ablation symptomatic and asymptomatic cerebral emboli as compared to pre-ablation. 
     
     
         14 . The device of  claim 1 , wherein the predetermined effectiveness rate is defined by evaluating a presence of emboli-associated neurological deficits by at least one of NIHSS and mRS assessments. 
     
     
         15 . The device of  claim 1 , wherein the end probe is configured for use in catheter-based cardiac electrophysiological mapping of the atria. 
     
     
         16 . The device of  claim 1 , wherein the end probe is configured for cardiac ablation. 
     
     
         17 . The device of  claim 1 , wherein the end probe comprises: the plurality of electrodes bonded to the first expandable membrane and configured to deliver Radio-Frequency energy to tissue of the pulmonary vein and sense temperature at each electrode. 
     
     
         18 . The device of  claim 1 , wherein the plurality of electrodes is oriented circularly to circumferentially contact with an ostia of the pulmonary vein. 
     
     
         19 . The device of  claim 1 , wherein the device is further configured for using the plurality of electrodes for visualization, stimulation, recording, and ablation. 
     
     
         20 . The device of  claim 1 , wherein each electrode is configured so an amount of power delivered to each electrode is controlled independently.