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

NCT01164319 | Completed Phase 3 DMC

• 2 other identifiers: AFERAWCLP-022RU AF 002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Percutaneous continous monitoring; ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3

  12 months

Secondary Outcomes (1)

• Freedom from AF in each group and the comparison of any group to each other

  12 months

Study Arms (4)

Group 1 (no early recurrence)

ACTIVE COMPARATOR

Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Group 2 (early AF recurrence)

ACTIVE COMPARATOR

Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Group 3 (early recurrence-no reablation)

ACTIVE COMPARATOR

Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Group 4 (early recurrence-early reablation)

ACTIVE COMPARATOR

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.

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Interventions

Circumferential PVI and subcutaneous cardiac monitor implantation PROCEDURE

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.

Group 1 (no early recurrence); Group 2 (early AF recurrence); Group 3 (early recurrence-no reablation); Group 4 (early recurrence-early reablation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

Related 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 Arrhythm Electrophysiol. 2011 Dec;4(6):823-31. doi: 10.1161/CIRCEP.111.964809. Epub 2011 Sep 19.

  PMID: 21930653 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evgeny A Pokushalov, MD, PhD

  State Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

RU (1)