Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488820
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-24
Brief Title:
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers SAFFICIENT
Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Organization:
Texas Cardiac Arrhythmia Research Foundation
Study Overview
Official Title:
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFFICIENT
Brief Summary:
Catheter ablation using radiofrequency RF energy has been widely adopted for management of atrial fibrillation AF for the past several years
However heterogeneity of outcomes and complication rates are still reported that have been partly attributed to operators experience and centers procedure volume 1 In a meta-analysis of 14 studies both hospital volume of 50 and 100 procedures per year were associated with significantly lower complication rate compared to 50year 2
Pulse-field ablation PFA is an emerging technology for AF management that has demonstrated tremendous potential in terms of preferential tissue ablation with no damage to the adjacent organs In the MANIFEST-PF survey 24 European centers participated that had a mean of 704 ablations per year with 733 range 7-291 PFA ablations annually 3 No post-PFA esophageal complications PV stenosis or persistent phrenic nerve injury were reported There appeared to be a trend toward fewer complications with center experience particularly for pericardial tamponade 3
However the impact of number of PFA performed on procedure-success and safety has not been evaluated in the US
This multicenter prospective study is designed to compare the incidence of adverse event AE and long-term procedural success of pulse-field ablation for AF in low volume 100year vs high volume 100year centers
However heterogeneity of outcomes and complication rates are still reported that have been partly attributed to operators experience and centers procedure volume 1 In a meta-analysis of 14 studies both hospital volume of 50 and 100 procedures per year were associated with significantly lower complication rate compared to 50year 2
Pulse-field ablation PFA is an emerging technology for AF management that has demonstrated tremendous potential in terms of preferential tissue ablation with no damage to the adjacent organs In the MANIFEST-PF survey 24 European centers participated that had a mean of 704 ablations per year with 733 range 7-291 PFA ablations annually 3 No post-PFA esophageal complications PV stenosis or persistent phrenic nerve injury were reported There appeared to be a trend toward fewer complications with center experience particularly for pericardial tamponade 3
However the impact of number of PFA performed on procedure-success and safety has not been evaluated in the US
This multicenter prospective study is designed to compare the incidence of adverse event AE and long-term procedural success of pulse-field ablation for AF in low volume 100year vs high volume 100year centers
Detailed Description:
Prospective non-randomized multi-center study NUMBER OF STUDY CENTERS Up to 80 TRIAL OBJECTIVE To evaluate safety of the VARIPULSE Catheter when used in conjunction with the TRUPULSE Generator for catheter ablation in low volume centers compared to high-volume centers for the treatment of subjects with symptomatic atrial fibrillation excluding long-standing persistent AF
HYPOTHESIS The low volume centers would be noninferior to high volume centers with respect to the proportion of patients experiencing at least one primary adverse event PAE
ABLATION PROCEDURE All left atrial ablations such as pulmonary vein isolation PVI and isolation of left atrial posterior wall will be performed using the PFA system If the right atrial structures are needed to be ablated ie cavotricuspid isthmus line coronary sinus a commercially approved radiofrequency RF catheter and compatible RF generator will be used
MANDATORY Minimum applications per vein is 12 Maximum applications per vein is 20 Ablation Outside the PV
Ablation outside the PVs will be performed only in the presence of spontaneous triggers or documentation that those locations are the sites for triggers responsible for re-initiation of the arrhythmia either spontaneously or after isoproterenol challenge For ablation outside the pulmonary vein the number of applications will be determined on a case- by-case basis based on the expected tissue thickness in the ablation area At a minimum at least 6 applications per area 3 applications at 2 catheter rotations should be considered Each lesion set attempted will be assessed for acute efficacy bi-directional block absence of detectable electrograms Additional lesions should be given until the acute endpoint is met
Posterior wall ablations Concentric overlapping ablations should be placed onto the posterior wall deliberately The catheter will be rotated once between a pair of applications briefly rotation is performed such that post-rotation the splines are situated midway between the splines pre- rotation positions The number of applications will be at the operators discretion
DURATION OF SUBJECT PARTICIPATION
11 months after the index ablation procedure 2 months blanking 9 months follow-up
DURATION OF STUDY 2-3 years 1-2 year of enrollment 11 months of study duration
STATISTICS
The sample size and power calculation were performed to establish noninferiority NI of low volume centers with respect to the primary safety endpoint With a NI margin of 004 an estimated sample size of 1084 patients per group will provide 80 power at one-sided significance level of 25 to declare non-inferiority Considering 5 oversampling for attrition 1138 patients will be enrolled per group
Interim analysis None planned
HYPOTHESIS The low volume centers would be noninferior to high volume centers with respect to the proportion of patients experiencing at least one primary adverse event PAE
ABLATION PROCEDURE All left atrial ablations such as pulmonary vein isolation PVI and isolation of left atrial posterior wall will be performed using the PFA system If the right atrial structures are needed to be ablated ie cavotricuspid isthmus line coronary sinus a commercially approved radiofrequency RF catheter and compatible RF generator will be used
MANDATORY Minimum applications per vein is 12 Maximum applications per vein is 20 Ablation Outside the PV
Ablation outside the PVs will be performed only in the presence of spontaneous triggers or documentation that those locations are the sites for triggers responsible for re-initiation of the arrhythmia either spontaneously or after isoproterenol challenge For ablation outside the pulmonary vein the number of applications will be determined on a case- by-case basis based on the expected tissue thickness in the ablation area At a minimum at least 6 applications per area 3 applications at 2 catheter rotations should be considered Each lesion set attempted will be assessed for acute efficacy bi-directional block absence of detectable electrograms Additional lesions should be given until the acute endpoint is met
Posterior wall ablations Concentric overlapping ablations should be placed onto the posterior wall deliberately The catheter will be rotated once between a pair of applications briefly rotation is performed such that post-rotation the splines are situated midway between the splines pre- rotation positions The number of applications will be at the operators discretion
DURATION OF SUBJECT PARTICIPATION
11 months after the index ablation procedure 2 months blanking 9 months follow-up
DURATION OF STUDY 2-3 years 1-2 year of enrollment 11 months of study duration
STATISTICS
The sample size and power calculation were performed to establish noninferiority NI of low volume centers with respect to the primary safety endpoint With a NI margin of 004 an estimated sample size of 1084 patients per group will provide 80 power at one-sided significance level of 25 to declare non-inferiority Considering 5 oversampling for attrition 1138 patients will be enrolled per group
Interim analysis None planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None