To determine the clinical effectiveness of HD mapping guided tailored ablation as compared to standard re-ablation that targets PV reconnection and antral tissue only in patients with symptomatic AF or AT requiring re-ablation after initial PVI.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful therapy defined as freedom from AF and AT, beyond three months of
blanking period during 12 months follow up without class I or III AAD.
Secondary outcome
To determine whether HD mapping guided antral re-ablation of the PVs and
additional tailored ablation improves AF related and general QoL as compared to
standard re-ablation that targets PV reconnection and antral tissue only in
patients with symptomatic AF requiring re-ablation after initial PVI during 6,
12 and 24 months follow up.
To determine from the viewpoint of society whether HD mapping guided ablation
as compared to standard re-ablation that targets PV reconnection and antral
tissue only in patients with symptomatic AF requiring re-ablation after initial
failed PVI can be preferred in terms of costs, effects and utilities.
Background summary
Pulmonary vein isolation is the cornerstone, and the only proven effective
invasive treatment method of atrial fibrillation in the absence of overt
underlying heart disease. Unfortunately 20-40% of the ablated patients
experience recurrent arrhythmia and a repeat procedure is generally considered.
Reconnection of one or more pulmonary veins is a common finding in these cases,
however, comparable rate of reconnection has also been demonstrated in patients
without arrhythmia recurrence. Furthermore, repeat ablation of these
reconnections does not eliminate the symptoms in all patients suggesting the
role of extrapulmonary triggers and substrate. In specific subset of patients
several studies have shown increased success rate of ablation when non-PV
triggers or left atrial low voltage area*s where involved in the ablation
procedure, however, there is still a need for solid evidence in patients with
recurrent atrial fibrillation and atrial tachycardia after initial pulmonary
vein isolation.
Study objective
To determine the clinical effectiveness of HD mapping guided tailored ablation
as compared to standard re-ablation that targets PV reconnection and antral
tissue only in patients with symptomatic AF or AT requiring re-ablation after
initial PVI.
Study design
This is a prospective randomized, controlled, two arm, multicenter, double
blind clinical study conducted in the Netherlands. Patients will be randomized
in a 1:1 ratio to receive either limited or extensive ablation as described
above.
Intervention
The standaard re-ablation approach involves antral re-isolation of the
pulmonary vein without any additional ablation.
The HD mapping guided ablation involves detailed LA voltage mapping in SR
and/or AF. In all patients antral re-isolation of the PVs will be performed. In
patients with a normal LA voltage and non-inducibility of AT/AFL/AF with pacing
and isoproterenol challenge: no further ablation. In patients with inducible
AT/AFL/AF: targeted ablation of documented or induced macro re-entrant atrial
tachycardia*s, ablation of focal ectopic atrial tachycardia*s, ablation of
reproducible non- PV triggers as described by Natale et al. and cavotricuspid
isthmus ablation in patients with typical AFL ablation, ablation or isolation
of left atrial low voltage areas.
In order to blind clinicians performing follow up, details about the performed
ablation will be noted exclusively in the ECRF.
Study burden and risks
No extra risks or benefits.
The risks of the ablation therapy are the same as routine treatment.
The difference is that not the investigator but the randomization determined
the treatment.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- Previous PVI without any further ablation lesions other than cavo-tricuspid
isthmus line due to atrial fibrillation.
- Clinical indication for redo ablation due to documented symptomatic atrial
fibrillation or atrial tachycardia lasting longer than 30 seconds
- Age 18 years or older
- Able and willing to comply with pre- and follow up testing and requirements
- Patient is willing and capable to provide written informed consent
Exclusion criteria
- LAVI > 60 ml/m2
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or
uncontrolled non-cardiac cause
- Contraindication to anticoagulation therapy (i.e. Heparin, NOAC*s or
acenocoumarol)
- Life expectancy less than 12 months
- Presence of intramural thrombus, tumor or other abnormality that precludes
catheter ablation.
Design
Recruitment
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 | NL66889.075.18 |