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Sponsors and Collaborators: |
Medtronic BRC Vitatron Medical Italia |
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Information provided by: | Medtronic BRC |
ClinicalTrials.gov Identifier: | NCT00239226 |
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 Procedure: RAA pacing |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Investigational New Drug Application/ Investigational Device Exemption Information |
Estimated Enrollment: | 300 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Giovanna Zucchi | +39 051 4188724 | giovanna.zucchi@vitatron.com |
Contact: Giorgio Corbucci, PhD | +39 051 4188711 | giorgio.corbucci@vitatron.com |
Italy, BS | |
Divisione di Cardiologia - Ospedale Civile | |
Desenzano, BS, Italy, 25015 | |
Italy, CO | |
Divisione di Cardiologia | |
Como, CO, Italy, 22100 | |
Italy, LI | |
Divisione di Cardiologia - Ospedale civile | |
Livorno, LI, Italy, 57100 | |
Italy, MI | |
Divisione di Cardiologia - Ospedale S. Gerardo | |
Monza, MI, Italy, 20052 | |
Divisione di Cardiologia - Ospedale Sacco | |
Milano, MI, Italy, 20157 | |
Italy, NO | |
Divisione di Cardiologia - Presidi Ospedalieri Riuniti | |
Borgomanero, NO, Italy, 28100 | |
Italy, PD | |
Divisione di Cardiologia - Ospedale P. Cosma | |
Camposampiero, PD, Italy, 35012 | |
Italy, PI | |
Divisione di Cardiologia - Ospedale Cisanello | |
Pisa, PI, Italy, 56127 | |
Divisione di Cardiologia - CRN | |
Pisa, PI, Italy, 56127 | |
Divisione di Cardiologia - Ospedale civile | |
Pontedera, PI, Italy, 56125 | |
Italy, PU | |
Divisione di Cardiologia - Ospedale di Fano | |
Fano, PU, Italy, 61032 | |
Italy, RI | |
Divisione di Cardiologia - Ospedale Civile | |
Rieti, RI, Italy, 2100 | |
Italy, RO | |
Divisione di Cardiologia - ULSS 18 | |
Rovigo, RO, Italy, 35100 | |
Italy, TA | |
Divisione di Cardiologia - Ospedale SS Annunziata | |
Taranto, TA, Italy, 74100 | |
Italy, to | |
Divisione di Cardiologia - Ospedale Molinette | |
Torino, to, Italy, 10126 | |
Divisione di Cardiologia - USL 7 | |
Chivasso, to, Italy, 10034 | |
Italy, TV | |
Divisione di Cardiologia - Presidio ospedaliero di Treviso | |
Treviso, TV, Italy, 31100 | |
Italy, VE | |
Divisione di Cardiologia - Azienda ospedaliera di Verona | |
Verona, VE, Italy, 37122 | |
Divisione di Cardiologia | |
Portogruaro, VE, Italy, 30027 | |
Divisione di Cardiologia - Ospedale Civile ULSS 13 | |
Mirano, VE, Italy, 30035 |
Study Director: | Giorgio Corbucci, PhD | Vitatron Medical Italia |
Principal Investigator: | Roberto Verlato, MD | Camposampiero Hospital |
Study ID Numbers: | EPASS |
Study First Received: | October 13, 2005 |
Last Updated: | October 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00239226 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
atrial fibrillation interatrial septum atrial pacing symptomatic sinus node dysfunction, pacemaker indication class I |
Heart Diseases Arrhythmia, Sinus Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |