Renal Function Post Cardioversion for Atrial Fibrillation

• Conditions: Cardioversion; Atrial Fibrillation; Renal Insufficiency
• Interventions: Other: Electrical atrial fibrillation Cardioversion; Other: Cardioversion

• Registration Number: NCT02742207
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-09
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-18
• Study Start: 2018-07-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07
• Primary Completion: 2020-07
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All patients with new onset atrial fibrillation

Exclusion Criteria

• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Cardioversion	All comers with Atrial fibrillation
Observational	Electrical atrial fibrillation Cardioversion	All comers with Atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Renal dysfunction	Short term - One month	Creatinine Clearance less 25 percent.

Secondary Outcome Measures

Name	Time	Method
Mortality	One year	Death

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel