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Table 3 Data collection schedule

From: Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry

 

Preoperative parameters

Surgery

Discharge

6 months

Year 1

Year 2

Registry exit

Adverse events

Signed informed consent

X

       

Inclusion/exclusion criteria

X

       

Baseline characteristics

X

       

Demographics and vital signs

X

       

Medical historya

X

       

Echo valve pathology

X

       

Laboratory/Symptoms

X

  

X

X

X

  

MRI

X

   

X

X

  

Access (Operative data)

 

X

      

Discharge data

  

X

     

Echocardiogram (TTE)

X

 

X

X

X

X

  

Echo form

  

X

X

X

X

  

6 Minute Walk Test

X

   

X

X

  

QoL questionnaire (SF-12)

X

  

X

X

X

  

Outcome questionsb

   

X

X

X

  

Expiration (death form)

  

X

X

X

X

  

Device and Patient success

  

X

     

Registry exit

      

X

 

Adverse events

   

X

X

X

 

X

  1. MRI magnetic resonance imaging, QoL quality of life, SF-12 short form-12, TTE transthoracic echocardiogram
  2. aIncludes current and previous cardiovascular and non‐cardiovascular conditions
  3. bIncludes occurrence of cardiovascular complications, site complications, and re-interventions since the last visit