CIAFL: Cryoablation in Patients With Atrial Flutter

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Unknown status

CT.gov ID

NCT01563848

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Flutter	Procedure: Cryoballoon ablation Procedure: Implantation of loop recorder Procedure: Radiofrequency ablation	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cryoablation in Patients With Atrial Flutter

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

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: 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).

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: 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

Procedure: Radiofrequency ablation

Outcome Measures

Primary Outcome Measures

Percentage of AF burden [3 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

Principal Investigator: Evgeny A Pokushalov, MD, PhD, State Research Institute of Circulation Pathology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

State Research Institute of Circulation Pathology Official Site

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT01563848

Other Study ID Numbers:

CAAF-712

First Posted:

Mar 27, 2012

Last Update Posted:

Sep 23, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Atrial Flutter

Study Results

No Results Posted as of Sep 23, 2015