Electrophysiologically Guided PAcing Site Selection Study (EPASS)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00239226
First received: October 13, 2005
Last updated: September 20, 2013
Last verified: April 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Investigational New Drug Application/ Investigational Device Exemption Information

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Persistent Atrial Fibrillation (AF) incidence


Secondary Outcome Measures:
  • Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Number of Patients With Permanent Atrial Fibrillation (AF) [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Symptom Scale Questionnaire: Comparison Between All Groups [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Number of Cardioversion: Comparison Between All Groups [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Heart Failure: Comparison Between All Groups [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Time to First Persistent Episode of Atrial Fibrillation (AF) [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Number of Episodes/Day [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • AF Burden [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Ventricular Pacing Percentage [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.

Additional 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
Study First Received: October 13, 2005
Results First Received: November 6, 2009
Last Updated: September 20, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014