Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539819
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
Rotor Modulation Ablation for the Treatment of Persistent Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Electrical Posterior Box Isolation and Rotor Modulation Ablation Versus Electrical Posterior Box Isolation Alone for the Treatment of Persistent Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For Persistent atrial fibrillation PeAF the therapeutic effect of catheter ablation needs to be further improved 3Circumferential pulmonary vein isolation CPVI is the cornerstone of catheter ablation of AF and additional ablation methods such as linear ablation or fragmentation potential ablation plus CPVI have been demonstrated to improve the treatment effect of PeAF but there is still a large gap with the ideal ablation treatment effectRecent studies have shown that the rotor is an important mechanism for the maintenance of PeAF and related studies have shown that rotor modulation ablation may further improve the success rate of catheter ablation for PeAF However on the one hand there is a lack of effective mapping catheter tool for rotor mapping and on the other hand the reproducibility of some related studies still needs to be further confirmed and further clinical studies are needed to explore whether rotor modulation ablation can improve the success rate of catheter ablation for PeAF The EnSite LiveView dynamic mapping system combined with the HD Grid mapping catheter provides a effective mapping tool for clinical surgeons In the early clinical practice we successfully completed the rotor mapping ablation using the mapping system and there was no complication during the operation which was safe and reliable and achieved good intraoperative and postoperative results We intend to conduct this clinical study to explore whether rotor ablation combined with BOX ablation can further improve the efficacy of PeAF compared with BOX ablation alone and provide guidance for catheter ablation treatment of PeAF This is a single-center randomized parallel-controlled single-blind clinical trial and we plan to enroll 360 subjects randomized into Electrical Posterior Box Isolation and Rotor Modulation Ablation group RB group and Electrical Posterior Box Isolation group BO group The corresponding surgery was performed according to the group and the postoperative follow-up was 12 months and the main observation endpoint was the remission rate of atrial fibrillation one year after surgery
Detailed Description:
1 Atrial fibrillation AF is a common arrhythmia and its incidence increases with age In addition AF is extremely harmful and studies have found that AF significantly increases mortality affects cardiac function increases the risk of arterial embolism eg stroke and reduces quality of life For rhythm control of AF catheter ablation has been shown to be superior to medical therapy
2 Persistent atrial fibrillation PeAF is one type of AF that lasts longer than 7 days and includes episodes that are terminated by cardioversion medical or electrical cardioversion after more than 7 days For PeAF the therapeutic effect of catheter ablation needs to be further improved
3 Circumferential pulmonary vein isolation CPVI is the cornerstone of catheter ablation of AF and additional ablation methods such as linear ablation or fragmentation potential ablation plus CPVI have been demonstrated to improve the treatment effect of PeAF but there is still a large gap with the ideal ablation treatment effect The reason of this dilemma is that the mechanism of occurrence and maintenance of AF is very complex which has not yet been fully clarified
4 Recent studies have shown that the rotor is an important mechanism for the maintenance of PeAF and related studies have shown that rotor modulation ablation may further improve the success rate of catheter ablation for PeAF
5 However on the one hand there is a lack of effective mapping catheter tool for rotor mapping and on the other hand the reproducibility of some related studies still needs to be further confirmed and further clinical studies are needed to explore whether rotor modulation ablation can improve the success rate of catheter ablation for PeAF
6 The EnSite LiveView dynamic mapping system combined with the HD Grid mapping catheter provides a effective mapping tool for clinical surgeons The planar design of the HD Grid mapping catheter allows it to fit perfectly against the endocardium The multi-directional perception function enables it to overcome the problem of bipolar blind spots The EnSite LiveView dynamic mapping system can help the surgeon determine the process and time point of each potential activation by uploading the dynamic rhythm in real time achieving better catheter stability compared to traditional mapping systems eliminating the need for secondary mapping or saving of mapping points and direct data interpretation when used with HD Grid catheters which gives it a strong advantage over other mapping electrodes in the mapping rotor
7 In the early clinical practice we successfully completed the rotor mapping ablation using the mapping system and there was no complication during the operation which was safe and reliable and achieved good intraoperative and postoperative results
8 At present for PeAF our center generally uses BOX ablation which is also one of the mainstream surgical methods for the treatment of PeAF in clinical practice We intend to conduct this clinical study to explore whether rotor ablation combined with BOX ablation can further improve the efficacy of PeAF compared with BOX ablation alone and provide guidance for catheter ablation treatment of PeAF
9 This is a single-center randomized parallel-controlled single-blind clinical trial and we plan to enroll 360 subjects randomized into Electrical Posterior Box Isolation and Rotor Modulation Ablation group RB group and Electrical Posterior Box Isolation group BO group The corresponding surgery was performed according to the group and the postoperative follow-up was 12 months and the main observation endpoint was the remission rate of atrial fibrillation one year after surgery
2 Persistent atrial fibrillation PeAF is one type of AF that lasts longer than 7 days and includes episodes that are terminated by cardioversion medical or electrical cardioversion after more than 7 days For PeAF the therapeutic effect of catheter ablation needs to be further improved
3 Circumferential pulmonary vein isolation CPVI is the cornerstone of catheter ablation of AF and additional ablation methods such as linear ablation or fragmentation potential ablation plus CPVI have been demonstrated to improve the treatment effect of PeAF but there is still a large gap with the ideal ablation treatment effect The reason of this dilemma is that the mechanism of occurrence and maintenance of AF is very complex which has not yet been fully clarified
4 Recent studies have shown that the rotor is an important mechanism for the maintenance of PeAF and related studies have shown that rotor modulation ablation may further improve the success rate of catheter ablation for PeAF
5 However on the one hand there is a lack of effective mapping catheter tool for rotor mapping and on the other hand the reproducibility of some related studies still needs to be further confirmed and further clinical studies are needed to explore whether rotor modulation ablation can improve the success rate of catheter ablation for PeAF
6 The EnSite LiveView dynamic mapping system combined with the HD Grid mapping catheter provides a effective mapping tool for clinical surgeons The planar design of the HD Grid mapping catheter allows it to fit perfectly against the endocardium The multi-directional perception function enables it to overcome the problem of bipolar blind spots The EnSite LiveView dynamic mapping system can help the surgeon determine the process and time point of each potential activation by uploading the dynamic rhythm in real time achieving better catheter stability compared to traditional mapping systems eliminating the need for secondary mapping or saving of mapping points and direct data interpretation when used with HD Grid catheters which gives it a strong advantage over other mapping electrodes in the mapping rotor
7 In the early clinical practice we successfully completed the rotor mapping ablation using the mapping system and there was no complication during the operation which was safe and reliable and achieved good intraoperative and postoperative results
8 At present for PeAF our center generally uses BOX ablation which is also one of the mainstream surgical methods for the treatment of PeAF in clinical practice We intend to conduct this clinical study to explore whether rotor ablation combined with BOX ablation can further improve the efficacy of PeAF compared with BOX ablation alone and provide guidance for catheter ablation treatment of PeAF
9 This is a single-center randomized parallel-controlled single-blind clinical trial and we plan to enroll 360 subjects randomized into Electrical Posterior Box Isolation and Rotor Modulation Ablation group RB group and Electrical Posterior Box Isolation group BO group The corresponding surgery was performed according to the group and the postoperative follow-up was 12 months and the main observation endpoint was the remission rate of atrial fibrillation one year after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None