Progressive Ventricular Dysfunction Prevention in Pacemaker Patients (Prevent-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170326
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 19, 2017
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Pacing Indication classI/IIa According AHA/ACC Procedure: dual-chamber pacemaker implantation Procedure: biventricular dual-chamber pacemaker implant Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Video tapes are provided by the central study organization and are labelled by numbers. The tapes are sent to the echocardiography core laboratory (Malaga, Spain) and are read by the Director of the Echo Core Lab (J.J. Gomez-Doblas). The echo examiner is blinded as to the point of time of the recording and assignment of treatment, although the presence of a LV lead may be adumbrated by visible artefacts.
Primary Purpose: Prevention
Official Title: Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
Study Start Date : January 2002
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Active Comparator: Dual Chamber pacing
conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex
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.
Other Name: DDD pacing, RV

Experimental: Biventricular pacing
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
Biventricular pacemaker system or in case in ICD indication a BIV ICD
Other Name: InSync 8040, InSync III 8042

Primary Outcome Measures :
  1. Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity. [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170326

Hospital General de Alicante
Alicante, Spain
H. Infanta Cristina
Badajoz, Spain
H. Clínic i Provincial
Barcelona, Spain
H. Puerta de Hierro
Madrid, Spain, 28035
H. C. U. Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Eduardo De Teresa, MD Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
Principal Investigator: Javier Alzueta, MD Hospital Clinico Universitario Virgen de la Victoria, Málaga, Spain
Principal Investigator: Ignacio Fernández Lozano, MD Hospital Puerta de Hierro, Madrid, Spain
Principal Investigator: Juan José Gómez Doblas, MD Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
Principal Investigator: Francisco Navarro López, MD Hospital Clinic i Provincial, Barcelona, Spain
Principal Investigator: A. Curnis, MD Ospedale Civile Brescia, Italy
Principal Investigator: Xavier Navarro Michel, MD Medtronic Ibérica, S.A., Barcelona, Spain
Principal Investigator: M. Stockburger, MD Charite, Campus Virchow-Klinikum, Berlin, Germany
Principal Investigator: Gervasio Lamas, MD Mount Sinai Clinical Center, Miami, FL, USA

Publications of Results:
Other Publications:
Responsible Party: Medtronic Bakken Research Center Identifier: NCT00170326     History of Changes
Other Study ID Numbers: PreVent-HF
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Bakken Research Center:
Permanent Pacing artificial internal

Additional relevant MeSH terms:
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases