Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Summary

The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.

Conditions

• Cardiac Pacing Indication classI/IIa According AHA/ACC

Interventions

PROCEDURE

dual-chamber pacemaker implantation

Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device.

PROCEDURE

biventricular dual-chamber pacemaker implant

Biventricular pacemaker system or in case in ICD indication a BIV ICD

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

  lead INDUSTRY

Principal Investigators

• Eduardo De Teresa, MD · Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain

• Javier Alzueta, MD · Hospital Clinico Universitario Virgen de la Victoria, Málaga, Spain

• Ignacio Fernández Lozano, MD · Hospital Puerta de Hierro, Madrid, Spain

• Juan José Gómez Doblas, MD · Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain

• Francisco Navarro López, MD · Hospital Clinic i Provincial, Barcelona, Spain

• A. Curnis, MD · Ospedale Civile Brescia, Italy

• Xavier Navarro Michel, MD · Medtronic Ibérica, S.A., Barcelona, Spain

• M. Stockburger, MD · Charite, Campus Virchow-Klinikum, Berlin, Germany

• Gervasio Lamas, MD · Mount Sinai Clinical Center, Miami, FL, USA

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-01-31

Primary Completion

2009-03-31

Completion

2009-03-31

Countries

• Spain

Study Locations