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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT02082366
First received: March 6, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation.
Device: TCD monitoring of microembolic signal during procedure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Microembolic Signals During CPVI (Circumferntial Pulmonary Vein Isolation) Assessed by TCD (Trans-cranial Doppler)

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Number of microembolic signals during CPVI [ Time Frame: During procedure - 4 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional irrigated ablation catheter

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
monitoring of microembolic signal during procedure
Active Comparator: nMARQ circumferential irrigated catheter

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
monitoring of microembolic signal during procedure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 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

Exclusion Criteria:

  • Special populations
  • Chronic Atrial fibrillation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082366

Contacts
Contact: Eran Leshem, MD 972-527360265 'eranleshem@gmail.com'

Locations
Israel
Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Eran Leshem, MD    972-527360265    'eranleshem@gmail.com'   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Rephael Rosso, MD Tel Aviv Medical Center
  More Information

No publications provided

Responsible Party: michal roll, R&D Tel-Aviv Sourasky Medical Center, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02082366     History of Changes
Other Study ID Numbers: TASMC-13-RR-560-CTIL
Study First Received: March 6, 2014
Last Updated: March 7, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Atrial fibrillation
CPVI
TCD
nMARQ
MES
microembolic signals

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014