"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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Novosibirsk, Ryska Federationen, 630055
- State Research Institute of Circulation Pathology
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group 1 (no early recurrence)
Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.
|
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. |
|
Aktiv komparator: Group 2 (early AF recurrence)
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.
|
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. |
|
Aktiv komparator: Group 3 (early recurrence-no reablation)
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.
|
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. |
|
Aktiv komparator: Group 4 (early recurrence-early reablation)
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Freedom from AF in each group and the comparison of any group to each other
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AFERAWCLP-022
- RU AF 002 (Annan identifierare: State Research Institute of Circulation Pathology)
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