- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040037
Cryoballoon Atrial Fibrillation Ablation Registry
March 21, 2022 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation.
This study is observational, prospective, multicenter, open-label
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this Registry is to describe characteristics of patients undergoing cryoballoon ablation, diversity of cryoablation techniques among different centers; to evaluate efficacy and safety of the procedure in the centers with different levels of experience.
Study Type
Observational
Enrollment (Actual)
1100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Petersburg, Russian Federation, 197341
- Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult Patient with Indications for Catheter Ablation of Atrial Fibrillation
Description
Inclusion Criteria:
- The indications for catheter ablation of atrial fibrillation
- Signed informed consent to participate in the Register
- Patients undergoing cryoballoon ablation
Exclusion Criteria:
- Left atrial thrombosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring
Time Frame: 1 Year
|
ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening)
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)
Time Frame: 1 Year
|
1 Year
|
|
Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)
Time Frame: 1 Year
|
1 Year
|
|
Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)
Time Frame: Above parameters will be assessed only during the procedure of cryoablation
|
Data will be collected using a web-based system of electronic case report forms
|
Above parameters will be assessed only during the procedure of cryoablation
|
Number of participants with antiarrhythmic drug treatment at 12 months
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
March 21, 2022
Study Registration Dates
First Submitted
December 5, 2016
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Actual)
April 1, 2022
Last Update Submitted That Met QC Criteria
March 21, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRAF-CA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
Abbott Medical DevicesRecruitingAtrial Fibrillation | Paroxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited States, Australia, Belgium, Germany, Spain, Netherlands, France, Austria, Canada, Czechia, Italy, United Kingdom
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom