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UNMASKING Study For Atrial Fibrillation Recurrences Typing in Early Postoperative Period

Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164319
Enrollment
150
Registered
2010-07-16
Start date
2008-02-29
Completion date
2010-11-30
Last updated
2012-04-24

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

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Percutaneous continous monitoring, ablation

Brief summary

The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.

Interventions

PROCEDURECircumferential PVI and subcutaneous cardiac monitor implantation

The left atrium (LA) and PVs were explored through a transeptal approach. Real-time 3D LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in one lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. The endpoint of ablation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity. The ICM (Reveal XT, Medtronic Inc) was implanted the day of the ablation procedure or 1 week before.The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* highly symptomatic patients refractory to at least two antiarrhythmic drugs * patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.

Exclusion criteria

* congestive heart failure * ejection fraction \<35% * left atrial diameter \>60 mm * previous ablation procedure

Design outcomes

Primary

MeasureTime frame
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 312 months

Secondary

MeasureTime frame
Freedom from AF in each group and the comparison of any group to each other12 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026