Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-02
Brief Title:
A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation Pulmonary Vein Isolation vs Adjunct Posterior Wall Isolation REPAIR PERS-AF Study
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation Pulmonary Vein Isolation vs Adjunct Posterior Wall Isolation REPAIR PERS-AF Study
Status:
NOT_YET_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:
REPAIR PERS-AF
Brief Summary:
This study aims to investigate the best strategy for repeat ablation of recurrent persistent atrial fibrillation AF after previous persistent AF ablation involving pulmonary vein isolation PVI along Patients with low voltage areas on the posterer wall will be randomized to PVI alone or the posterer wall isoaltion PWI in addition to PVI
Detailed Description:
This study aims to find a optmal strategy for repeat ablation for recurrent persistent AF after previous persistent AF ablation involving only PVI PVI is an evident and well documented target for AF ablation Many other ablation approaches beyond PVI have been reported PWI is one of the frequently applied methods However this appoach has not been studied in randomized clinical trials for recurrent persistent AF after index procedure thus evidence is demanded for guidance of clinical practice for AF ablation
The purpose of this study is to clarify this matter by comparing PVI alone strategy with the approach of PVI plus PWI in patients with recurrent persistent AF after index ablation procedure Since previous clinical studies have shown better outcomes of ablation among patients with normal left atrium LA than those with sick LA ablation strategies in this study will be selected based on voltage mapping of the LA avoiding unnecessary ablation applications
The investigators hypothesize that PVI is good enough for patients with normal LA normal voltage 05 mV Among patients with low voltagescar voltage 05 mV PVI plus PWI is superior to PVI alone
This study is a prospective multi-center open-labeled partly randomized study After enrollment patients will receive a voltage mapping of the LA which is routine for all AF ablation procedures Based on the mapping results patients will be stratified into two strata normal voltage 05 mV and low voltage 05 mV in the LA posterior wall Patients with normal voltage in the LA posterior wall will be directly assigned to arm 1 receiving PVI alone treatment avoid unnecessary ablation of healthy myocardium Patients with low voltage will be 11 randomized in arms 2 and 3 receiving either PVI alone or PVI PWI treatment
1 Arm 1 Normal voltage in LA posterior wall - PVI alone
2 Arm 2 Low voltage in LA posterior wall - PVI alone
3 Arm 3 Low voltage in LA posterior wall - PVI PWI
Three Norwegian University Hospitals including Haukeland University Hospital Bergen St Olavs Hospital Trondheim and University Hospital of North Norway Tromsø will participate in this study The study is expected to last 3 years 24 months for enrollment and each patient will be followed for a period of 12 months
In order to minimize bias subjects will be randomized next to the LA mapping Patients will be analyzed according to their initial randomization that is intention-to-treat even if they never start the treatment or discontinue or cross over the group
Patents will be followed in out-patient clinic at 3 6 and 12 months after the treatment
The purpose of this study is to clarify this matter by comparing PVI alone strategy with the approach of PVI plus PWI in patients with recurrent persistent AF after index ablation procedure Since previous clinical studies have shown better outcomes of ablation among patients with normal left atrium LA than those with sick LA ablation strategies in this study will be selected based on voltage mapping of the LA avoiding unnecessary ablation applications
The investigators hypothesize that PVI is good enough for patients with normal LA normal voltage 05 mV Among patients with low voltagescar voltage 05 mV PVI plus PWI is superior to PVI alone
This study is a prospective multi-center open-labeled partly randomized study After enrollment patients will receive a voltage mapping of the LA which is routine for all AF ablation procedures Based on the mapping results patients will be stratified into two strata normal voltage 05 mV and low voltage 05 mV in the LA posterior wall Patients with normal voltage in the LA posterior wall will be directly assigned to arm 1 receiving PVI alone treatment avoid unnecessary ablation of healthy myocardium Patients with low voltage will be 11 randomized in arms 2 and 3 receiving either PVI alone or PVI PWI treatment
1 Arm 1 Normal voltage in LA posterior wall - PVI alone
2 Arm 2 Low voltage in LA posterior wall - PVI alone
3 Arm 3 Low voltage in LA posterior wall - PVI PWI
Three Norwegian University Hospitals including Haukeland University Hospital Bergen St Olavs Hospital Trondheim and University Hospital of North Norway Tromsø will participate in this study The study is expected to last 3 years 24 months for enrollment and each patient will be followed for a period of 12 months
In order to minimize bias subjects will be randomized next to the LA mapping Patients will be analyzed according to their initial randomization that is intention-to-treat even if they never start the treatment or discontinue or cross over the group
Patents will be followed in out-patient clinic at 3 6 and 12 months after the treatment
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?:
False
Is an FDA AA801 Violation?:
None