Cryoablation in Patients With Atrial Flutter

Atrial Flutter Clinical Trial

— CIAFL  

Official title:

Cryoablation in Patients With Atrial Flutter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01563848
• Other study ID #: CAAF-712
• Status: Recruiting
• Phase: Phase 2
• First received: March 23, 2012
• Last updated: September 21, 2015
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Evgeny Pokushalov, MD, PhD
• Phone: +79139254858
• Email: E.Pokushalov[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

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.
• 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
• 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 ?ow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of AF burden		3 years	Yes
Secondary	All-cause death		3 years	Yes
Secondary	thromboembolic events		3 years	Yes
Secondary	hospitalizations		3 years	Yes
Secondary	procedural complications		3 years	Yes
Secondary	drug adverse effects		3 years	Yes
Secondary	number of crossovers		3 years	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site