Renal Function Post Cardioversion for Atrial Fibrillation
AFCARD-II
Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation
1 other identifier
observational
150
1 country
1
Brief Summary
Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. In a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described after cardioversion is pulmonary edema. In this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. In addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to assess hemodynamic changes the investigators will use a non-invasive FDA approved device called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedStudy Start
First participant enrolled
July 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 7, 2019
August 1, 2019
2 years
April 9, 2016
August 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Renal dysfunction
Creatinine Clearance less 25 percent.
Short term - One month
Secondary Outcomes (1)
Mortality
One year
Study Arms (1)
Observational
All comers with Atrial fibrillation
Interventions
Electrical cardioversion for patients admitted for Atrial Fibrillation
Electrical cardioversion for patients admitted for Atrial Fibrillation
Eligibility Criteria
All patients with new onset atrial fibrillation. Meaning less than three days.
You may qualify if:
- All patients with new onset atrial fibrillation
You may not qualify if:
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
Related Publications (1)
Hellman Y, Cohen MJ, Leibowitz D, Loncar S, Gozal D, Haviv YS, Haber G, Afifi M, Rosenheck S, Lotan C, Pollak A, Gilon D. The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Cardiology. 2013;124(3):184-9. doi: 10.1159/000346618. Epub 2013 Mar 9.
PMID: 23485988RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Non-Invasive Cardiology/Echocardiography
Study Record Dates
First Submitted
April 9, 2016
First Posted
April 18, 2016
Study Start
July 11, 2018
Primary Completion
July 1, 2020
Study Completion
December 1, 2020
Last Updated
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share