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Standard re-ablation versus advanced HD mapping guided ablation in recurrent symptomatic atrial fibrillation or atrial tachycardia after initial pulmonary vein isolation

Standard re-ablation versus advanced HD mapping guided ablation in recurrent symptomatic atrial fibrillation or atrial tachycardia after initial pulmonary vein isolation - HD REDO-AF

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49664
Enrollment
238
Registered
2020-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation or atrial tachycardia after initial pulmonal vein isolation. Irregular heart rate

Interventions

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/

Sponsors

Maatschap Cardiologie Zwolle
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)