Cryoablation in Patients With Atrial Flutter
CIAFL
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 23, 2015
September 1, 2015
3.8 years
March 23, 2012
September 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of AF burden
3 years
Secondary Outcomes (6)
All-cause death
3 years
thromboembolic events
3 years
hospitalizations
3 years
procedural complications
3 years
drug adverse effects
3 years
- +1 more secondary outcomes
Study Arms (2)
Group 1 (RFA CTI+Reveal)
ACTIVE COMPARATORassessing the incidence of atrial fibrillation in patients with atrial flutter
Group 2 (RFA CTI+Cryo PVI+Reveal)
ACTIVE COMPARATORefficacy of cryoablation in patients with atrial flutter
Interventions
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.
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
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- a history of atrial fibrillation
- Previous AF ablation procedure
- Congestive heart failure
- Left Ventricle ejection fraction less than 35%
- Unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Publications (1)
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.
PMID: 29570894DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeny A Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 27, 2012
Study Start
September 1, 2011
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
September 23, 2015
Record last verified: 2015-09