Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Medtronic Cardiac Rhythm and Heart Failure108 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

108

Conditions

Cardiac Pacing Indication classI/IIa According AHA/ACC

Interventions

dual-chamber pacemaker implantationPROCEDURE

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

biventricular dual-chamber pacemaker implantPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meet Class I and/or Class IIa implantation criteria for permanent cardiac pacing according to the guidelines given by the American College of Cardiology (ACC)/American Heart Association(AHA). Exclusion Criteria: * Expected ventricle stimulation \<80% of the time * Impossibility of dual chamber stimulation in the absence of AF * Severe heart failure (NYHA Functional class III-IV) previous to indication for pacing device implant * Patient needs revascularization within 3 months * Myocardial infarction in the last 3 months * Cardiac surgery performed in the last 3 months * Hypertrophic cardiomyopathy * Constrictive pericarditis * Bad echo window * Previous system implanted (ICD or pacemaker) * Aortic stenosis * Patient has a mechanical right heart valve * Patient \<18 years * Pregnancy * Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation * Life expectancy \<1year * Patient is unwilling or unable to cooperate or give written informed consent. * Patient is or will be inaccessible for follow-up at the study center. * Patients who are participating or planning to participate in other clinical trials during the clinical study

Locations (5)

Hospital General de Alicante

Alicante, Spain

H. Infanta Cristina

Badajoz, Spain

H. Clínic i Provincial

Barcelona, Spain

H. Puerta de Hierro

Madrid, Spain

H. C. U. Virgen de la Victoria

Outcomes

Primary Outcomes

Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.

Time frame: 12 months

Secondary Outcomes

Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.

Time frame: 12 months

Data from ClinicalTrials.gov

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