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Status unknownNCT02742207AFCARD-IIUpdated Aug 7, 2019

Renal Function Post Cardioversion for Atrial Fibrillation

An observational study in Atrial Fibrillation, Renal Insufficiency and Cardioversion, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-07.

Sponsored by Hadassah Medical Organization · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atrial Fibrillation
  • Renal Insufficiency
  • Cardioversion
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 150 is close to the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with new onset atrial fibrillation. Meaning less than three days.

Inclusion criteria

  • All patients with new onset atrial fibrillation

Exclusion criteria

Exclusion Criteria:

  • Pregnant
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observational

    All comers with Atrial fibrillation

    Other: Electrical atrial fibrillation Cardioversion · Other: Cardioversion

Interventions

  • OtherElectrical atrial fibrillation Cardioversion

    Electrical cardioversion for patients admitted for Atrial Fibrillation

    Also known as: Cardioversion

  • OtherCardioversion

    Electrical cardioversion for patients admitted for Atrial Fibrillation

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What researchers measure

Primary outcomes

  1. Renal dysfunction

    Creatinine Clearance less 25 percent.

    Time frame: Short term - One month

Secondary outcomes

  1. Mortality

    Death

    Time frame: One year

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Study locations

1 of 1 sites recruiting
  • Hadassah Medical Organization
    Jerusalem, 91120, Israel
    Recruiting
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References and documents

Publications

  • 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. PubMed 23485988 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02742207
Lead sponsor
Hadassah Medical Organization
Responsible party
Dan Gilon (Director, Non-Invasive Cardiology/Echocardiography, Hadassah Medical Organization) — Principal investigator
First posted
Apr 18, 2016
Start date
Jul 11, 2018
Primary completion
Jul 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Aug 7, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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