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Cryoballoon Atrial Fibrillation Ablation Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040037
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
RUSSIAN SOCIETY OF CARDIOLOGY
Information provided by (Responsible Party):
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Brief Summary:
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label

Condition or disease
Atrial Fibrillation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
  2. Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation) [ Time Frame: 1 Year ]
  3. 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

  4. Number of participants with antiarrhythmic drug treatment at 12 months [ Time Frame: 1 Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Patient with Indications for Catheter Ablation of Atrial Fibrillation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040037


Contacts
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Contact: Evgeny Mikhaylov, MD, PhD +79217553237 evgenymikhaylov@gmail.com

Locations
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Russian Federation
Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation Recruiting
Saint-Petersburg, Russian Federation, 197341
Contact: EVGENY MIKHAYLOV, MD, PhD    0078127023700    evgenymikhaylov@gmail.com   
Sponsors and Collaborators
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
RUSSIAN SOCIETY OF CARDIOLOGY
Additional Information:

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Responsible Party: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
ClinicalTrials.gov Identifier: NCT03040037    
Other Study ID Numbers: PRAF-CA
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes