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Cryoablation in Patients With Atrial Flutter (CIAFL)

Primary Purpose

Atrial Flutter

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Cryoballoon ablation
Implantation of loop recorder
Radiofrequency ablation
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 (RFA CTI+Reveal)

Group 2 (RFA CTI+Cryo PVI+Reveal)

Arm Description

assessing the incidence of atrial fibrillation in patients with atrial flutter

efficacy of cryoablation in patients with atrial flutter

Outcomes

Primary Outcome Measures

Percentage of AF burden

Secondary Outcome Measures

All-cause death
thromboembolic events
hospitalizations
procedural complications
drug adverse effects
number of crossovers

Full Information

First Posted
March 23, 2012
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01563848
Brief Title
Cryoablation in Patients With Atrial Flutter
Acronym
CIAFL
Official Title
Cryoablation in Patients With Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (RFA CTI+Reveal)
Arm Type
Active Comparator
Arm Description
assessing the incidence of atrial fibrillation in patients with atrial flutter
Arm Title
Group 2 (RFA CTI+Cryo PVI+Reveal)
Arm Type
Active Comparator
Arm Description
efficacy of cryoablation in patients with atrial flutter
Intervention Type
Procedure
Intervention Name(s)
Cryoballoon ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Implantation of loop recorder
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of AF burden
Time Frame
3 years
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
3 years
Title
thromboembolic events
Time Frame
3 years
Title
hospitalizations
Time Frame
3 years
Title
procedural complications
Time Frame
3 years
Title
drug adverse effects
Time Frame
3 years
Title
number of crossovers
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Romanov, MD, PhD
Phone
+79137172652
Email
abromanov@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny A Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD,PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29570894
Citation
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.
Results Reference
derived
Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site

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Cryoablation in Patients With Atrial Flutter

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