Cryoablation in Patients With Atrial Flutter (CIAFL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01563848
First received: March 23, 2012
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Atrial Flutter
Procedure: Cryoballoon ablation
Procedure: Implantation of loop recorder
Procedure: Radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cryoablation in Patients With Atrial Flutter

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Percentage of AF burden [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • thromboembolic events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • hospitalizations [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • procedural complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • drug adverse effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • number of crossovers [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563848

Contacts
Contact: Evgeny Pokushalov, MD, PhD +79139254858 E.Pokushalov@gmail.com
Contact: Alexander Romanov, MD, PhD +79137172652 abromanov@mail.ru

Locations
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD,PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

Additional Information:
No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01563848     History of Changes
Other Study ID Numbers: CAAF-712
Study First Received: March 23, 2012
Last Updated: November 29, 2013
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014