Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)

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: NCT03303872
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker implantation and assess long term clinical results.

Condition or disease
Post Pacemaker Implantation Patients

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
Actual Study Start Date : December 31, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
AF-pacemaker registry



Primary Outcome Measures :
  1. Occurrence of subclinical atrial fibrillation (atrial high rate episode) [ Time Frame: 3 months after pacemaker implantation ]
  2. Occurrence of subclinical atrial fibrillation (atrial high rate episode) [ Time Frame: 6 months after pacemaker implantation ]
  3. Occurrence of subclinical atrial fibrillation (atrial high rate episode) [ Time Frame: every 1 year upto 3 years after pacemaker implantation ]
    Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant

  4. Occurrence of stroke [ Time Frame: 3 months after pacemaker implantation ]
    Stroke based on device detected subclinical atrial fibrillation episodes

  5. Occurrence of stroke [ Time Frame: 6 months after pacemaker implantation ]
    Stroke based on device detected subclinical atrial fibrillation episodes

  6. Occurrence of stroke [ Time Frame: every 1 year upto 3 years after pacemaker implantation ]
    Stroke based on device detected subclinical atrial fibrillation episodes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients post pacemaker implantation
Criteria

Inclusion Criteria:

  • Age: 18-80 years
  • Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
  • Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
  • Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
  • Patients who are willing to sign the informed consent.
  • Patients who are willing to receive the implantation and post-operative follow-up.

Exclusion Criteria:

  • Persistent or permanent AF
  • Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
  • Thyroid gland dysfunction
  • Pregnancy
  • Malignant tumor
  • Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
  • Life expectancy < 12 months
  • Patients unable or unwilling to cooperate in the study procedures.

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): NCT03303872


Contacts
Layout table for location contacts
Contact: Boyoung Joung, M.D., Ph.D. 82-10-8025-0424 CBY6908@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Boyoung Joung, M.D., Ph.D.    82-10-8025-0424    CBY690@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Additional Information:

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03303872     History of Changes
Other Study ID Numbers: 1-2017-0008
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
atrial high rate episode
pacemaker
atrial fibrillation
stroke
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Atrioventricular Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Block
Cardiac Conduction System Disease