Cryoablation in Patients With Atrial Flutter - Full Text View

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
Primary Completion Date:	May 2013 (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).

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

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:

State Research Institute of Circulation Pathology Official Site This link exits the ClinicalTrials.gov site

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:	May 22, 2013
Health Authority:	Russia: Ethics Committee

Additional relevant MeSH terms:

Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013

Cryoablation in Patients With Atrial Flutter (CIAFL)