Electrophysiologically Guided PAcing Site Selection Study

Condition(s) targeted: Sinus Arrhythmia; Atrial Fibrillation

Intervention: IAS pacing (Procedure); RAA pacing (Procedure)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Medtronic BRC

Official(s) and/or principal investigator(s):
Giorgio Corbucci, PhD, Study Director, Affiliation: Vitatron Medical Italia
Roberto Verlato, MD, Principal Investigator, Affiliation: Camposampiero Hospital

Overall contact:
Giovanna Zucchi, Phone: +39 051 4188724, Email: giovanna.zucchi@vitatron.com

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).

Official title: Investigational New Drug Application/ Investigational Device Exemption Information

Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Number of patients with persistent AF at 2 year follow-up: comparison between IAS and RAA pacing in the group with severe conduction delay

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Giovanna Zucchi, Phone: +39 051 4188724, Email: giovanna.zucchi@vitatron.com

Divisione di Cardiologia - Ospedale Civile, Desenzano, BS 25015, Italy

Divisione di Cardiologia, Como, CO 22100, Italy

Divisione di Cardiologia - Ospedale civile, Livorno, LI 57100, Italy

Divisione di Cardiologia - Ospedale S. Gerardo, Monza, MI 20052, Italy

Divisione di Cardiologia - Ospedale Sacco, Milano, MI 20157, Italy

Divisione di Cardiologia - Presidi Ospedalieri Riuniti, Borgomanero, NO 28100, Italy

Divisione di Cardiologia - Ospedale P. Cosma, Camposampiero, PD 35012, Italy

Divisione di Cardiologia - Ospedale Cisanello, Pisa, PI 56127, Italy

Divisione di Cardiologia - CRN, Pisa, PI 56127, Italy

Divisione di Cardiologia - Ospedale civile, Pontedera, PI 56125, Italy

Divisione di Cardiologia - Ospedale di Fano, Fano, PU 61032, Italy

Divisione di Cardiologia - Ospedale Civile, Rieti, RI 2100, Italy

Divisione di Cardiologia - ULSS 18, Rovigo, RO 35100, Italy

Divisione di Cardiologia - Ospedale SS Annunziata, Taranto, TA 74100, Italy

Divisione di Cardiologia - Presidio ospedaliero di Treviso, Treviso, TV 31100, Italy

Divisione di Cardiologia - Ospedale Civile ULSS 13, Mirano, VE 30035, Italy

Divisione di Cardiologia, Portogruaro, VE 30027, Italy

Divisione di Cardiologia - Azienda ospedaliera di Verona, Verona, VE 37122, Italy

Divisione di Cardiologia - Ospedale Molinette, Torino, to 10126, Italy

Divisione di Cardiologia - USL 7, Chivasso, to 10034, Italy

Related publications:

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Last updated: October 24, 2006