Clinical trial NCT00239226: Electrophysiologically Guided PAcing Site Selection Study
Official title: Investigational New Drug Application/ Investigational Device Exemption Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinus Arrhythmia
Atrial Fibrillation
Keywords: atrial fibrillation
interatrial septum
atrial pacing
symptomatic sinus node dysfunction,
pacemaker indication class I
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-10-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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 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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups
timeFrame: January 2009
measure: Number of Patients With Permanent Atrial Fibrillation (AF)
timeFrame: January 2009
measure: Symptom Scale Questionnaire: Comparison Between All Groups
timeFrame: January 2009
measure: Number of Cardioversion: Comparison Between All Groups
timeFrame: January 2009
measure: Heart Failure: Comparison Between All Groups
timeFrame: January 2009
measure: Time to First Persistent Episode of Atrial Fibrillation (AF)
timeFrame: January 2009
measure: Number of Episodes/Day
timeFrame: January 2009
measure: AF Burden
timeFrame: January 2009
measure: Ventricular Pacing Percentage
timeFrame: January 2009
Other outcomes:
Locations:
city: Desenzano
country: Italy
facility: Azienda Ospedaliera di Desenzano del Garda
state: BS
city: Como
country: Italy
facility: Divisione di Cardiologia
state: CO
city: Pisa
country: Italy
facility: Divisione di Cardiologia - CRN
state: PI
city: Pisa
country: Italy
facility: Divisione di Cardiologia - Ospedale Cisanello
state: PI
city: Fucecchio
country: Italy
facility: Divisione di Cardiologia - Ospedale San Pietro Igneo
state: Prato
city: Torino
country: Italy
facility: Divisione di Cardiologia - Ospedale Molinette
state: TO
city: Mirano
country: Italy
facility: Divisione di Cardiologia - Ospedale Civile ULSS 13
state: VE
city: Borgomanero
country: Italy
facility: Divisione di Cardiologia - Presidi Ospedalieri Riuniti
Study officials:
affiliation: Medtronic
name: Giorgio Corbucci, PhD
role: STUDY_DIRECTOR
affiliation: Camposampiero Hospital
name: Roberto Verlato, MD
role: PRINCIPAL_INVESTIGATOR
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