Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Conditions
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Cardiac Pacing Indication classI/IIa According AHA/ACC

Intervention / Treatment
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* Procedure: dual-chamber pacemaker implantation
* Procedure: biventricular dual-chamber pacemaker implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dual Chamber pacing<br>conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex | Procedure: dual-chamber pacemaker implantation<br>* Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device.<br>* Other names: DDD pacing, RV;|
| Experimental: Biventricular pacing<br>Biventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle | Procedure: biventricular dual-chamber pacemaker implant<br>* Biventricular pacemaker system or in case in ICD indication a BIV ICD<br>* Other names: InSync 8040, InSync III 8042;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Permanent Pacing artificial internal