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Cryoablation in Patients With Atrial Flutter

NCT01563848 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-09-23

No results posted yet for this study

Summary

The investigators hypothesized that revealing the incidence of AF following RFA of the CTI and cryoablation PVI reduces incidence of AF following RFA of the CTI.

Conditions

  • Atrial Flutter

Interventions

PROCEDURE

Cryoballoon ablation

After double transseptal puncture, selective PV angiography was performed to identify the PV ostia in 2 projections (right anterior oblique 30º, left anterior oblique 40 º). Baseline potentials of all PVs were recorded with a Lasso catheter (Biosense Webster, Inc., Diamond Bar, California). To assess the exact position of the inflated balloon in relation to the left atrial (LA)-PV junction, contrast medium was injected from the distal lumen of the cryoballon catheter . CBA was performed for a target time of 300 seconds. The right phrenic nerve was constantly paced from the superior caval vein during freezing at the septal PVs. After each freeze, PV conduction was revaluated by the Lasso catheter.

PROCEDURE

Implantation of loop recorder

The RevealXT 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. Patients were provided with the Patient Assistant, a toolthat allows each patient to store the ECG through the implanted device during symptoms: datawere collected in order to analyze heart rhythm during symptomatic events

PROCEDURE

Radiofrequency ablation

Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a flow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Evgeny A Pokushalov, MD, PhD · State Research Institute of Circulation Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563848 on ClinicalTrials.gov