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Electrophysiologically Guided PAcing Site Selection Study (EPASS)

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ClinicalTrials.gov Identifier: NCT00239226
Recruitment Status : Completed
First Posted : October 14, 2005
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Sinus Arrhythmia Atrial Fibrillation Procedure: IAS pacing - study group Procedure: IAS pacing control group Procedure: Pacing RAA study group Procedure: Pacing RAA control group Phase 4

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Investigational New Drug Application/ Investigational Device Exemption Information
Study Start Date : November 2005
Primary Completion Date : December 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1. IAS pacing - study group

Patients were first submitted to electrophysiological study to assess Delta CTos > or < 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (1) includes patients with Delta CTos >50 ms and randomized IAS pacing.

IAS Pacing -Study Group: Patients with Delta CTos >50 ms (study group) at the electrophysiologic study and randomized Interatrial Septum Pacing

Procedure: IAS pacing - study group
site of implant and permanent pacing
Experimental: 2. IAS pacing-control group

(Delta CTos<50ms)

Patients were first submitted to electrophysiological study to assess Delta CTos > or < 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (2) includes patients with Delta CTos <50 ms and randomized IAS pacing.

IAS Pacing -Control Group: Patients with Delta CTos <50 ms (control group) at the electrophysiologic study and randomized Interatrial Septum Pacing

Procedure: IAS pacing control group
site of implant and permanent pacing
Active Comparator: 3. RAA Pacing - study group

Patients were first submitted to electrophysiological study to assess Delta CTos > or < 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (3) includes patients with Delta CTos >50 ms and randomized Right Atrial Appendage pacing.

RAA Pacing -Study Group: Patients with Delta CTos >50 ms (study group) at the electrophysiologic study and randomized Right Atrial Appendage pacing

Procedure: Pacing RAA study group
site of implant and permanent pacing
Active Comparator: 4. RAA Pacing - control group

Patients were first submitted to electrophysiological study to assess Delta CTos > or < 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (4) includes patients with Delta CTos <50 ms and randomized Right Atrial Appendage pacing.

RAA Pacing -Control Group: Patients with Delta CTos <50 ms (control group) at the electrophysiologic study and randomized Right Atrial Appendage pacing

Procedure: Pacing RAA control group
site of implant and permanent pacing


Outcome Measures

Primary Outcome Measures :
  1. Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group [ Time Frame: 1 year ]
    Persistent Atrial Fibrillation (AF) incidence


Secondary Outcome Measures :
  1. Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups [ Time Frame: January 2009 ]
  2. Number of Patients With Permanent Atrial Fibrillation (AF) [ Time Frame: January 2009 ]
  3. Symptom Scale Questionnaire: Comparison Between All Groups [ Time Frame: January 2009 ]
  4. Number of Cardioversion: Comparison Between All Groups [ Time Frame: January 2009 ]
  5. Heart Failure: Comparison Between All Groups [ Time Frame: January 2009 ]
  6. Time to First Persistent Episode of Atrial Fibrillation (AF) [ Time Frame: January 2009 ]
  7. Number of Episodes/Day [ Time Frame: January 2009 ]
  8. AF Burden [ Time Frame: January 2009 ]
  9. Ventricular Pacing Percentage [ Time Frame: January 2009 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239226


Locations
Italy
Azienda Ospedaliera di Desenzano del Garda
Desenzano, BS, Italy
Divisione di Cardiologia
Como, CO, Italy, 22100
Divisione di Cardiologia - CRN
Pisa, PI, Italy, 56127
Divisione di Cardiologia - Ospedale Cisanello
Pisa, PI, Italy, 56127
Divisione di Cardiologia - Ospedale San Pietro Igneo
Fucecchio, Prato, Italy
Divisione di Cardiologia - Ospedale Molinette
Torino, TO, Italy, 10126
Divisione di Cardiologia - Ospedale Civile ULSS 13
Mirano, VE, Italy, 30035
Divisione di Cardiologia - Presidi Ospedalieri Riuniti
Borgomanero, Italy, 28100
Sponsors and Collaborators
Medtronic BRC
Medtronic
Investigators
Study Director: Giorgio Corbucci, PhD Medtronic
Principal Investigator: Roberto Verlato, MD Camposampiero Hospital
More Information

Publications:
8. Daubert C, Mabo B, Berder V. Arrhythmia prevention by permanent atrial resynchronization in advanced interatrial block. Eur Heart J 1990;11: 237-42.
11. Prakash A, Giorgberidze I. Endocardial mapping of sites of conduction delay for atrial premature beats in patients with atrial fibrillation. PACE 1997;20 (part II):1161.
19. Attuel P, Pellerin D, Gaston J et al: Latent atrial vulnerability: new means of electrophysiologic investigation in atrial arrhythmias. In Attuel P, Coumel P, Janse M,eds:The Atrium in Health and Disease.Futura Publishing Co.,Inc.,Mt.Kisco,NY,1989,pp159-200.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT00239226     History of Changes
Other Study ID Numbers: EPASS
First Posted: October 14, 2005    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: April 2012

Keywords provided by Medtronic BRC:
atrial fibrillation
interatrial septum
atrial pacing
symptomatic sinus node dysfunction,
pacemaker indication class I

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes