to determine if freedom of AF may be improved by delivering more, and targeted PFA applications while avoiding side-effects of higher PFA dosing.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the primary study parameter for efficacy is the freedom of atrial arrhythmias
after the 2-month blanking period up to 12 months after the procedure. The
primary safety outcome is the major adverse event rate of the higher dosing
versus the standard dosing arm. The primary safety outcome is the major adverse
event rate of the higher dosing versus the standard dosing arm.
Secondary outcome
Extent and position of pulmonary vein reconnection during redo procedures
required because of recurrence of arrhythmias that constitute an endpoint in
the study.
Arrhythmia burden post-procedure in centers that also use
photo-phlethysmografic remote-monitoring as standard of care for all their
ablation patients.
Background summary
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely
accepted interventional treatment for patients with symptomatic atrial
fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation
modalities use radiofrequency energy or cryo-energy to create cardiac tissue
lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is
a novel technology for cardiac tissue ablation. Initial studies have shown
favorable outcome data in patients with AF treated by performing PVI. However,
freedom of AF so far is not superior to existing thermal ablation and appears
similarly related to suboptimal durability of lesion formation leading to
electrical reconnection. In addition, while classic complications of thermal
ablation seem to be mostly avoided, new side-effects such as hemolysis have
also emerged possibly related to dosing. Thus, the optimal balance between
efficacy and safety is not clearly understood at this time
Study objective
to determine if freedom of AF may be improved by delivering more, and targeted
PFA applications while avoiding side-effects of higher PFA dosing.
Study design
DOPPIO is single-blinded randomized controlled clinical trial.
Intervention
Patients will undergo the standard catheter ablation procedure in accordance
with good clinical practice, performing PVI with the pentaspline PFA system. In
the control group PVI will be performed with 4 basket- and 4 flower-shaped
applications of the catheter per pulmonary vein, while in the study group 2
olive-, 4 basket-, and 6 flower shaped applications will be delivered for each
pulmonary vein. All other procedural steps will be the same between groups.
Study burden and risks
Patients in the study will be exposed to the same low procedural risks as
patients that will be treated with PFA outside of the study. Additional risks
of participation in the study are considered marginal based on prior
publications in patients when more than 32 but fewer than 60 applications were
used during a PFA procedure.
The risk of the additional time and manoeuvring of the catheter to perform the
extra ablations is considered low (5-10 minutes) in comparison to the average
total procedure time (45-60 min)
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Patients with paroxysmal atrial fibrillation or persistent atrial fibrillation
who have undergone no more than 1 cardioversion and are usually in SR, between
18 and 80 years of age, who will be treated with the pentaspline PFA ablation
system, have no contraindication to ablation and its associated procedures, and
are able to understand and complete the study for a follow-up duration of >12
months
Exclusion criteria
Patients with chronic atrial fibrillation, younger than 18 years of age, with
moderate-severe valvular disease, a severely dilated left atrium, heart
failure, COPD GOLD 3 or more, moderate to severe OSAS, serious cardiac disease
for which a cardiac intervention in the last or next 3 months, anatomical
features that make ablation impossible, CVA in the last 6 months, kidney
disease with GFR<45 ml/m2/min
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88354.100.24 |