Cryoablation in Patients With Atrial Flutter (CIAFL)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Flutter
• Intervention / Treatment: Procedure: Implantation of loop recorder; Procedure: Radiofrequency ablation; Procedure: Cryoballoon ablation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexander Romanov, MD, PhD; Phone Number: +79137172652; Email: abromanov@mail.ru

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • State Research Institute of Circulation Pathology
    • Contact: Evgeny Pokushalov, MD,PhD; Phone Number: +79139254858; Email: E.Pokushalov@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (RFA CTI+Reveal); assessing the incidence of atrial fibrillation in patients with atrial flutter	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).
Active Comparator: Group 2 (RFA CTI+Cryo PVI+Reveal); efficacy of cryoablation in patients with atrial flutter	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).; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of AF burden	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause death	3 years
thromboembolic events	3 years
hospitalizations	3 years
procedural complications	3 years
drug adverse effects	3 years
number of crossovers	3 years

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

General Publications

• Romanov A, Pokushalov E, Bayramova S, Ponomarev D, Shabanov V, Losik D, Stenin I, Elesin D, Mikheenko I, Steinberg JS. Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: Three-year outcomes of the PREVENT AF I study. J Cardiovasc Electrophysiol. 2018 Jun;29(6):872-878. doi: 10.1111/jce.13485. Epub 2018 Apr 6.

Helpful Links

• State Research Institute of Circulation Pathology Official Site

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 27, 2012

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: CAAF-712