"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164319
• Other study ID #: AFERAWCLP-022
• Secondary ID: RU AF 002
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2010
• Last updated: April 23, 2012
• Start date: February 2008
• Est. completion date: November 2010

Study information

• Verified date: April 2012
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Circumferential 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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Turov A, Shirokova N, Karaskov A. Use of an implantable monitor to detect arrhythmia recurrences and select patients for early repeat catheter ablation for atrial fibrillation: a pilot study. Circ Arrhyth — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3		12 months	Yes
Secondary	Freedom from AF in each group and the comparison of any group to each other		12 months	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site