Atrial FlutterPhase 2CIAFLNCT01563848
Cryoablation in Patients With Atrial Flutter
A Phase 2 study testing Cryoballoon ablation, Implantation of loop recorder and Radiofrequency ablation in people with Atrial Flutter, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Cryoballoon ablation, Implantation of loop recorder and Radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2011to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- a history of atrial fibrillation
- Previous AF ablation procedure
- Congestive heart failure
- Left Ventricle ejection fraction less than 35%
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of Circulation Pathology
Novosibirsk, 630055
Evgeny Pokushalov, MD,PhD, +79139254858, E.Pokushalov@gmail.com
Evgeny Pokushalov, MD, PhD
About this study
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.
- Conditions
- Atrial Flutter
- Being tested
- Cryoballoon ablation, Implantation of loop recorder, Radiofrequency ablation
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon ablationProcedure or surgery
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.
Implantation of loop recorderProcedure or surgery
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
Radiofrequency ablationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (RFA CTI+Reveal) | Active comparator | assessing the incidence of atrial fibrillation in patients with atrial flutter Receives: Procedure: Implantation of loop recorder; Procedure: Radiofrequency ablation |
| Group 2 (RFA CTI+Cryo PVI+Reveal) | Active comparator | efficacy of cryoablation in patients with atrial flutter Receives: Procedure: Cryoballoon ablation; Procedure: Implantation of loop recorder; Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of AF burden
Measured: 3 years
Secondary outcomes (6)
All-cause death
Measured: 3 years
thromboembolic events
Measured: 3 years
hospitalizations
Measured: 3 years
procedural complications
Measured: 3 years
drug adverse effects
Measured: 3 years
number of crossovers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Evgeny A Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563848
- Sponsor's protocol ID
- CAAF-712
- Acronym
- CIAFL
- Status last verified
- Sep 2015
- First submitted
- 23 Mar 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29570894
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation in Patients With Atrial Flutter
- ClinicalTrials.gov ID
- NCT01563848
- Acronym / sponsor ID
- CIAFL / CAAF-712
- Conditions
- Atrial Flutter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (RFA CTI+Reveal) | Active comparator | Procedure: Implantation of loop recorder, Procedure: Radiofrequency ablationassessing the incidence of atrial fibrillation in patients with atrial flutter |
| Group 2 (RFA CTI+Cryo PVI+Reveal) | Active comparator | Procedure: Cryoballoon ablation, Procedure: Implantation of loop recorder, Procedure: Radiofrequency ablationefficacy of cryoablation in patients with atrial flutter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- a history of atrial fibrillation
- Previous AF ablation procedure
- Congestive heart failure
- Left Ventricle ejection fraction less than 35%
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon ablationAfter 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 or surgery | Group 2 (RFA CTI+Cryo PVI+Reveal) |
| Implantation of loop recorderThe 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 or surgery | Group 1 (RFA CTI+Reveal), Group 2 (RFA CTI+Cryo PVI+Reveal) |
| Radiofrequency ablationExternally-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). | Procedure or surgery | Group 1 (RFA CTI+Reveal), Group 2 (RFA CTI+Cryo PVI+Reveal) |
Primary outcome
Percentage of AF burden
Time frame: 3 years
6 secondary outcomes
All-cause death
Time frame: 3 years
thromboembolic events
Time frame: 3 years
hospitalizations
Time frame: 3 years
procedural complications
Time frame: 3 years
drug adverse effects
Time frame: 3 years
number of crossovers
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 29570894Romanov 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.
- State Research Institute of Circulation Pathology Official SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny A Pokushalov, MD, PhD principal investigator
State Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryoballoon ablation, Implantation of loop recorder and Radiofrequency ablation in people with Atrial Flutter, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Pokushalov, MD, PhD (+79139254858, E.Pokushalov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of AF burden (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.