Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06098989 |
Other study ID # |
626136 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 15, 2023 |
Est. completion date |
November 15, 2026 |
Study information
Verified date |
September 2023 |
Source |
Haukeland University Hospital |
Contact |
Kristian Wollner, MD |
Phone |
92229412 |
Email |
wollnerkristian[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 ≥0.5 mV); Among patients with low voltage/scar (voltage < 0.5 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 (≥ 0.5 mV) and low voltage (< 0.5 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 1:1 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.