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Catheter Ablation vs. Risk Factor Modification.

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: NCT04011800
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
General Teaching Hospital, Prague
Masaryk University
Information provided by (Responsible Party):
Pavel Osmancik, Charles University, Czech Republic

Brief Summary:
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence of 2% in general population. Incidence and prevalence of AF has been slightly increasing due to increasing age, improved ability to treat cardiac diseases, and higher incidence of obesity and other risk factors associated with AF. AF is associated with higher morbidity and mortality mainly caused by heart failure and stroke. Catheter ablation (with pulmonary vein isolation as a cornerstone) presents the most effective treatment method of AF. Recent observational studies have shown that intensive risk factor and lifestyle modifications, such as weight loss, reduced alcohol intake, and increased physical activity, are also associated with improved rhythm outocome. Head-to-head comparison of this very different methods has not been done yet. The aim of the project is to compare the effect of catheter ablation with lifestyle modification (risk factor modification) in a prospective, randomized, multicenter study on the maintenance of sinus rhythm (monitored using implantable ECG reveal), and on the progression of the fibrosis of the left ventricle.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation Combination Product: Risk Factor Modification Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient will be randomized into catheter ablation arm or risk factor modification arm
Masking: None (Open Label)
Masking Description: prospective, randomized, open - label study
Primary Purpose: Treatment
Official Title: Catheter Ablation vs. Risk Factor Modification. A Randomized Study
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Catheter ablation
Patients will undergo catheter ablation of atrial fibrillation.
Procedure: Catheter ablation
Pulmonary vein isolation, or additional left or righ atrial lession.

Experimental: Risk factor modification
Patiemt will undergo risk factor intervention (dietary intervention, physical intervention, alcohol reduction or abstinence)
Combination Product: Risk Factor Modification
dietary restriction, physical exercise, reduced alcohol intake




Primary Outcome Measures :
  1. Freeedom from atrial fibrillation and/or atrial tachycardia [ Time Frame: 12 months ]
    An absence of any paroxysm of atrial fibrillaton or atrial tachycardia lasting then 30 second, as assessed using implantable ECG loop recorder

  2. AF burden [ Time Frame: 12 months ]
    The percent of time spending in atrial fibrillation or atrial arrhythmia, as assessed using implantable ECG loop recorder

  3. Changes of fibrosis of the left ventricle (% of the left ventricular mass) [ Time Frame: 12 months ]
    Cardiac MRI will be done at the beginning, and at 1 year to compare the myocardial fibrosis


Secondary Outcome Measures :
  1. Hospitalization for AF [ Time Frame: 12 months ]
    The number of hospitalizations or emergency visits due AF

  2. A composite of stroke, cardiovascular death, or hospitalization for heart failure [ Time Frame: 12 months ]
    Clinical endpoint, composite number of events associated with AF

  3. Changes in QoL questionnaires between baseline and 1 year [ Time Frame: 12 months ]
    Change in quality of life, assessed by specific questionnaire in one year

  4. Weight [ Time Frame: 12 months ]
    Change in weight between between baseline and 12 month level

  5. Fasting glucose [ Time Frame: 12 months ]
    Change in fasting glucose between baseline and 12 month level

  6. Triglycerides [ Time Frame: 12 months ]
    Change in trigylcerides between baseline and 12 month level

  7. Interleukin-6 [ Time Frame: 12 months ]
    Change in interleukin-6 concentration between baseline and 12 month level



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (all three must be met):

  • symptomatic atrial fibrillation
  • BMI ≥ 25, and
  • signed informed content

Exclusion Criteria:

  • permanent AF
  • severe valve disease
  • left ventricular ejection fraction < 40%
  • severe pulmonary hypertension (PAP > 60 mm Hg)
  • history of tachycardia-induced cardiomyopathy
  • planned revascularization
  • pregnancy
  • left atrial size ≥ 60 mm
  • BMI ≤ 20 or BMI ≥ 40
  • indication for surgical treatment of obesity
  • age ≥ 75 let
  • a significant physical limitation that could affect physical activity (musculoskeletal disorders, COPD)
  • life expectancy less than 2 years

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): NCT04011800


Locations
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Czechia
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Sponsors and Collaborators
Charles University, Czech Republic
General Teaching Hospital, Prague
Masaryk University
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Responsible Party: Pavel Osmancik, head of the department of cardiac arrhythmias, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT04011800    
Other Study ID Numbers: CA-RFM
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pavel Osmancik, Charles University, Czech Republic:
atrial fibrillation
catheter ablation
risk factor modification
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes