NCT00170326

Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The interventricular synchrony is one of the components of a proper cardiac function. When there is no synchrony -as in left bundle block (LBBB)- the clinic consequences should have little importance in patients with a healthy heart or a great importance in patients suffering heart failure (HF), specially in those with severe grade of HF, the benefit of cardiac resynchronization by pacing both ventricles or left ventricle (LV)should means healthy improvement in patients. All previous studies done in HF, are in patients with symptomatic HF. The importance of stop progression of latent HF in patients with asymptomatic ventricular dysfunction (VD)in permanent pacing indication patients. Pacing may accelerate HF progression by dissincronyzing ventricles. ACE inhibitors studies in asymptomatic VD gave positive results. The PreVent-HF is an international, multicenter, prospective, randomized, single-blinded pilot trial specifically designed to evaluate as main objective the progression of VD in permanent pacing population.

Conditions

• Cardiac Pacing Indication classI/IIa According AHA/ACC

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-09-15
• Last updated: 2025-07-03

Locations

5 sites across 1 country: Spain