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Table 2 List of all investigational-specific activities/procedures

From: Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial

 

Time point

Enrollment

Implant

Pre-discharge

6-12-24 month follow-up

Implant

6-12-24 month follow-up

 

Study activity

ALL patients

 

MPP group

 

Standard ICD group

Enrollment

Low-dose dobutamine stress echocardiography

X

     

Informed consent process

X

     

Verification of inclusion/exclusion criteria

X

     

Demographics and medical history

X

     

Randomization

X

     

Intervention:

MPP device implant

 

X

    

Standard ICD implant

    

X

 

Assessment

Fluoro images and/or cine of venogram and final lead position, two projections

 

X

  

X

 

Capture thresholds and signal amplitude measurements on RA and RV leads

 

X

X

X

X

X

Capture thresholds and phrenic nerve stimulation occurrence at LV pacing configurations

 

X

X

X

  

NYHA functional class

X

  

X

 

X

QRS duration

X

 

X

X

 

X

Standard echo measurements

X

  

X

 

X

Electrical delay measurements

  

X

X

  

QRS optimization

  

X

X

  

12-lead ECG during QRS optimization

  

X

X

  

Echo measurements and AV optimization

  

X

X

  

Optimal programming of the device

  

X

X

  
  1. MPP multipoint pacing, ICD implantable cardioverter defibrillator, RA right atrium, RV right ventricle, LV left ventricle NYHA New York Heart Association, ECG electrocardiogram, AV atrioventricular