Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Cardiac Pacing Indication classI/IIa According AHA/ACC Clinical Trial

— Prevent-HF  

Official title:

Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170326
• Other study ID #: PreVent-HF
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 18, 2017
• Start date: January 2002
• Est. completion date: March 2009

Study information

• Verified date: April 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Pacing Indication classI/IIa According AHA/ACC
• Ventricular Dysfunction

Intervention

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.
• biventricular dual-chamber pacemaker implant
Biventricular pacemaker system or in case in ICD indication a BIV ICD

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Spain, 

References & Publications (3)

de Teresa E, Gómez-Doblas JJ, Lamas G, Alzueta J, Fernández-Lozano I, Cobo E, Navarro X, Navarro-López 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. Epub 2007 Apr 25. — View Citation

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 fr — View Citation

Stockburger M, Gómez-Doblas JJ, Lamas G, Alzueta J, Fernández-Lozano I, Cobo E, Wiegand U, Concha JF, Navarro X, Navarro-López F, de Teresa E. Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: results from a multicen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.		12 months
Secondary	Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.		12 months