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Completed

NCT Number: NCT00170326

Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Alicante, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dual-chamber pacemaker implantation

Procedure

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

Other names: DDD pacing, RV

biventricular dual-chamber pacemaker implant

Procedure

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

Other names: InSync 8040, InSync III 8042

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: Prevent-HF

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.