Microembolic Signals During CPVI (Circumferntial Pulmonary Vein Isolation) Assessed by TCD (Trans-cranial Doppler)

NCT02082366 | Completed

• 1 other identifier: TASMC-13-RR-560-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigators study is to analyze the incidence of MES by TCD performed during AF ablation with the nMARQ and to compare is with the incidence of MES using a conventional irrigated ablation catheter. Objective: To investigate the incidence of MES on TCD during AF ablation with the nMARQ catheter compared to a conventional irrigated ablation catheter. Following inclusion, patients will be randomized into 2 equal different treatment groups: PVI with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In all patients, anticoagulation therapy with warfarin is discontinued five-days before the procedure and low molecular weight heparin is initiated at that time. A CT-scan of the left atrium is performed and imported into the Carto 3 mapping system. The ablation procedure is conducted under general anesthesia or conscious sedation. A decapolar catheter is positioned in the coronary sinus and a quadripolar catheter is positioned at the His bundle level through the right femoral vein. Two 8F sheaths are introduced into the left atrium with double trans-septal puncture performed under fluoroscopic, trans-esophageal echocardiographic or intracardiac echocardiography guidance. Upon completion of the first trans-septal puncture, intravenous heparin is administered to maintain an activated clotting time of 350 seconds throughout the procedure. A variable Lasso circular mapping catheter is introduced through the SL1 sheath into each pulmonary vein for electrical mapping. After the second trans-septal puncture, a Navistar Thermocool 3.5mm irrigated ablation catheter or an nMARQ circular irrigated ablation catheter are introduced into the left atrium. Of note, in case of use the nMARQ catheter, the second SL-1 sheath is replaced by a steerable 8F agilis sheath after the second trans-septal puncture. Each of the 4 PVs are imaged by selective angiograms. The left atrium geometry is created using the nMARQ catheter or the Navistar catheter and then merged with the pre-acquired CT scan of the left atrium and PVs. Identification of true MESs will be possible using an event detector system, in addition to determining whether the MESs are attributed to a solid or to a gaseous embolus. Total MES counts will be collected and evaluated separately during different stages of the procedure.

Conditions

Atrial Fibrillation.

Keywords

Atrial fibrillation; CPVI; TCD; nMARQ; MES; microembolic signals

Outcome Measures

Primary Outcomes (1)

• Number of microembolic signals during CPVI

  During procedure - 4 hours

Study Arms (2)

conventional irrigated ablation catheter

ACTIVE COMPARATOR

TCD testing during procedure from trans-septal puncture until completion using a conventional irrigated ablation catheter. Intervention: TCD monitoring of microembolic signal during procedure

Device: TCD monitoring of microembolic signal during procedure

nMARQ circumferential irrigated catheter

ACTIVE COMPARATOR

TCD testing during procedure from trans-septal puncture until completion using the nMARQ circumferential irrigated catheter. Intervention: TCD monitoring of microembolic signal during procedure

Device: TCD monitoring of microembolic signal during procedure

Interventions

TCD monitoring of microembolic signal during procedure DEVICE

monitoring of microembolic signal during procedure

conventional irrigated ablation catheter; nMARQ circumferential irrigated catheter

Eligibility Criteria

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

You may qualify if:

• patients undergoing pulmonary vein isolation (PVI) for highly symptomatic, drug refractory paroxysmal or persistent AF.
• Above 18 years of age
• Following the signing of informed consent

You may not qualify if:

• Special populations
• Chronic Atrial fibrillation

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Rephael Rosso, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R&D Tel-Aviv Sourasky Medical Center

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)