Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

NCT ID: NCT00170326

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2009-03-31

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.

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.

Conditions

Cardiac Pacing Indication classI/IIa According AHA/ACC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dual Chamber pacing

conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex

Group Type: ACTIVE_COMPARATOR

dual-chamber pacemaker implantation

Intervention Type: PROCEDURE

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

Biventricular pacing

Biventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle

Group Type: EXPERIMENTAL

biventricular dual-chamber pacemaker implant

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

biventricular dual-chamber pacemaker implant

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

Intervention Type: PROCEDURE

Other Intervention Names

DDD pacing, RV; InSync 8040, InSync III 8042

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo De Teresa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain

Javier Alzueta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario Virgen de la Victoria, Málaga, Spain

Ignacio Fernández Lozano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro, Madrid, Spain

Juan José Gómez Doblas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain

Francisco Navarro López, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic i Provincial, Barcelona, Spain

A. Curnis, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile Brescia, Italy

Xavier Navarro Michel, MD

Role: PRINCIPAL_INVESTIGATOR

Medtronic Ibérica, S.A., Barcelona, Spain

M. Stockburger, MD

Role: PRINCIPAL_INVESTIGATOR

Charite, Campus Virchow-Klinikum, Berlin, Germany

Gervasio Lamas, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Clinical Center, Miami, FL, USA

Locations

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

Málaga, , Spain

Countries

Spain

References

de Teresa E, Gomez-Doblas JJ, Lamas G, Alzueta J, Fernandez-Lozano I, Cobo E, Navarro X, Navarro-Lopez F, Stockburger M. Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: rationale and design of the PREVENT-HF study. Europace. 2007 Jun;9(6):442-6. doi: 10.1093/europace/eum064. Epub 2007 Apr 25.

Reference Type: BACKGROUND

PMID: 17460018 (View on PubMed)

Stockburger M, Gomez-Doblas JJ, Lamas G, Alzueta J, Fernandez-Lozano I, Cobo E, Wiegand U, Concha JF, Navarro X, Navarro-Lopez F, de Teresa E. Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: results from a multicentre international randomized trial (PREVENT-HF). Eur J Heart Fail. 2011 Jun;13(6):633-41. doi: 10.1093/eurjhf/hfr041.

Reference Type: RESULT

PMID: 21613427 (View on PubMed)

Stockburger M, de Teresa E, Lamas G, Desaga M, Koenig C, Habedank D, Cobo E, Navarro X, Wiegand U. Exercise capacity and N-terminal pro-brain natriuretic peptide levels with biventricular vs. right ventricular pacing for atrioventricular block: results from the PREVENT-HF German Substudy. Europace. 2014 Jan;16(1):63-70. doi: 10.1093/europace/eut217. Epub 2013 Jul 16.

Reference Type: RESULT

PMID: 23861381 (View on PubMed)

Other Identifiers

PreVent-HF

Identifier Type: -

Identifier Source: org_study_id