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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00170326
First received: September 13, 2005
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Cardiac Pacing Indication classI/IIa According AHA/ACC
Device: Biventricular Pacing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: January 2002
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Conventional Pacing
Device: Biventricular Pacing
Conventional Pacing vs biventricular pacing
Other Name: Medtronic, prevent-HF, CRT
Experimental: 2
Biventricular pacing
Device: Biventricular Pacing
Conventional Pacing vs biventricular pacing
Other Name: Medtronic, prevent-HF, CRT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170326

Locations
Spain
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
Medtronic
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic, Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00170326     History of Changes
Other Study ID Numbers: PreVent-HF
Study First Received: September 13, 2005
Last Updated: April 21, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Ventricular Dysfunction
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014