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Electrophysiologically Guided PAcing Site Selection Study
This study is not yet open for participant recruitment.
Study NCT00239226   Information provided by Medtronic BRC
First Received: October 13, 2005   Last Updated: October 24, 2006   History of Changes

October 13, 2005
October 24, 2006
 
 
Number of patients with persistent AF at 2 year follow-up: comparison between IAS and RAA pacing in the group with severe conduction delay
Number of patients with persistent AF at 2 year follow-up: comparison between IAS and RAA pacing in the group with severe conduction delay.
Complete list of historical versions of study NCT00239226 on ClinicalTrials.gov Archive Site
  • Number of patients with persistent AF at 2 year follow-up: comparison between all groups
  • Number of persistent AF episodes: comparison between all groups
  • Number of patients with permanent AF
  • Symptom scale questionnaire: comparison between all groups
  • Number of cardioversion: comparison between all groups
  • Heart failure: comparison between all groups
  • Time to first persistent episode of AF
  • Number of episodes/day
  • AF burden
  • Time to first paroxysmal episode
  • Ventricular pacing percentage
  • Average sinus rhythm duration
  • 1. Number of patients with persistent AF at 2 year follow-up: comparison between all groups
  • 2. Number of persistent AF episodes: comparison between all groups
  • 3. Number of patients with permanent AF
  • 4. Symptom scale questionnaire: comparison between all groups
  • 5. Number of cardioversion: comparison between all groups
  • 6. Heart failure: comparison between all groups
  • 7. Time to first persistent episode of AF
  • 8. Number of episodes/day
  • 9. AF burden
  • 10. Time to first paroxysmal episode
  • 11. Ventricular pacing percentage
  • 12. Average sinus rhythm duration
 
Electrophysiologically Guided PAcing Site Selection Study
Investigational New Drug Application/ Investigational Device Exemption Information

This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial appendage (RAA).

The EPASS is a multicenter, prospective, randomized, and controlled study.

Prior to entering the study, the patient should be informed and provide a written consent. In addition, the patient should meet all selection criteria. The Investigator has to check that all selection criteria are satisfied. Then the patient undergoes pacemaker implantation, receiving a pacemaker model T70 or Selection 9000 (or later version).

Patients eligible for the study are enrolled and submitted to the evaluation of intra-light atrial conduction delay before device implantation. Besides, they are assigned to the group with severe RA conduction delay or with normal conduction delay. The randomization of the pacing site for both groups depends on the value of right atrial conduction delay, together with the associated diseases of the patients, sex and age. After implantation, a stabilization phase of 3-5 weeks is required to stabilize the leads: during this period the physician can optimize the device parameters. Neither the data regarding AF episodes nor cardioversion are collected.

At the end of the stabilization phase the patient undergoes the 1st study follow-up and starts the monitoring period lasting 2 years. Regular follow-ups and data collection are scheduled every 6 months.

Phase IV
Interventional
Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
  • Sinus Arrhythmia
  • Atrial Fibrillation
  • Procedure: IAS pacing
  • Procedure: RAA pacing
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
300
 
 

Inclusion Criteria:

  • Symptomatic sinus node dysfunction
  • More than 18 years old
  • Signed informed consent

Exclusion Criteria:

  • Less than 18 years old
  • Pregnancy
  • Anamnestic transient ischemic attack (TIA) or stroke
  • Neoplastic or any other severe disease reducing life expectancy
  • Heart surgery in the last 3 months
  • Left atrial diameter > 55mm, determined in the parasternal long-axis view (during either sinus rhythm or atrial fibrillation)
  • Participation in other studies
Both
18 Years and older
No
Contact: Giovanna Zucchi +39 051 4188724 giovanna.zucchi@vitatron.com
Contact: Giorgio Corbucci, PhD +39 051 4188711 giorgio.corbucci@vitatron.com
Italy
 
NCT00239226
 
EPASS
Medtronic BRC
Vitatron Medical Italia
Study Director: Giorgio Corbucci, PhD Vitatron Medical Italia
Principal Investigator: Roberto Verlato, MD Camposampiero Hospital
Medtronic BRC
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP