Skip to content

Cryoablation in Patients With Atrial Flutter

Cryoablation in Patients With Atrial Flutter

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01563848
Acronym
CIAFL
Enrollment
80
Registered
2012-03-27
Start date
2011-09-30
Completion date
2015-09-30
Last updated
2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Flutter

Brief 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.

Interventions

PROCEDURECryoballoon 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.

PROCEDUREImplantation 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

PROCEDURERadiofrequency 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

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * ECG documented paroxysmal or persistent AFL * No prior documented history of AF * Patient undergoing RFA of the CTI for AFL. * No indication (other than AFL) for continued anticoagulation with warfarin. * No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device) * Availability of an analog phone line.

Exclusion criteria

* a history of atrial fibrillation * Previous AF ablation procedure * Congestive heart failure * Left Ventricle ejection fraction less than 35% * Unwillingness to participate

Design outcomes

Primary

MeasureTime frame
Percentage of AF burden3 years

Secondary

MeasureTime frame
thromboembolic events3 years
hospitalizations3 years
All-cause death3 years
drug adverse effects3 years
number of crossovers3 years
procedural complications3 years

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD
E.Pokushalov@gmail.com+79139254858
Backup ContactAlexander Romanov, MD, PhD
abromanov@mail.ru+79137172652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026