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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02742207
Other study ID # HMO-15-0645
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 11, 2018
Est. completion date December 2020

Study information

Verified date August 2019
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients with new onset atrial fibrillation

Exclusion Criteria:

- Pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electrical atrial fibrillation Cardioversion
Electrical cardioversion for patients admitted for Atrial Fibrillation
Cardioversion
Electrical cardioversion for patients admitted for Atrial Fibrillation

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Renal dysfunction Creatinine Clearance less 25 percent. Short term - One month
Secondary Mortality Death One year
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