Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505163
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2020-07-10
Brief Title:
Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
Sponsor:
Dignity Health Medical Foundation
Organization:
Dignity Health Medical Foundation
Study Overview
Official Title:
Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation PIVoTAL - IDE Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
PIVoTAL-IDE
Brief Summary:
The purpose of this study it to learn whether pulmonary vein isolation PVI along with isolation of the posterior left atrial wall PWI in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation AF recurrence in patients with persistent atrial fibrillation at 12 months after a single ablation procedure in comparison to PVI alone
The investigator hypothesizes that the combination of PVI PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation
The investigator hypothesizes that the combination of PVI PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation
Detailed Description:
Patients with persistent atrial fibrillation will be enrolled in this multi-center randomized prospective single-blinded study After catheter ablation isolation of the pulmonary veins PVI and while still in the cardiac electrophysiology laboratory all patients will be randomized to either PVI alone or the combination of PVI posterior left atrial wall isolation PWI For patients randomized to PVI their ablation procedure will be completed at that time For those patients randomized to PVI PWI they will have additional ablation to achieve PWI
All study patients will have the same follow-up after their ablation procedure including clinic visits at 3 6 and 12 months and a heart event monitor for 7-14 days before these visits An echocardiogram heart ultrasound is performed at 6 to 12 months after the ablation Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patients medical history stroke risk and the decision of the study doctor Information about the patients medical history heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed
All study patients will have the same follow-up after their ablation procedure including clinic visits at 3 6 and 12 months and a heart event monitor for 7-14 days before these visits An echocardiogram heart ultrasound is performed at 6 to 12 months after the ablation Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patients medical history stroke risk and the decision of the study doctor Information about the patients medical history heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None