Progressive Ventricular Dysfunction Prevention in Pacemaker Patients - Full Text View

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00170326

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
Candidates to Permanent Cardiac Pacing Indication Class I/IIa According AHA/ACC/NASPE	Device: Conventional Pacing vs Biventricular Pacing	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
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.

Secondary Outcome Measures:

. Combined endpoint of cardiac mortality, appearance of heart failure (HF)(as defined by the Diagnosis Guides of the Spanish Society of Cardiology)and hospitalization due to cardiovascular problems.
· Morbidity
· Necessity for or changes in medication due to heart failure: ACE inhibitors, beta blockers and/or diuretics.
· Appearance of or worsening of mitral insufficiency.

Estimated Enrollment:	100
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2006

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

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

Contacts

Contact: Maria Paz Lopez	+34 676483429	mari.paz.lopez@medtronic.com
Contact: Xavier Navarro, MD	+34 93 4775192	xavier.navarro@medtronic.com

Locations

Spain
Hospital General de Alicante	Active, not recruiting
Alicante, Spain
H. Infanta Cristina	Recruiting
Badajoz, Spain
Contact: Joaquin Fernandez de la Concha, MD
Principal Investigator: Joaquín Fernández de la Concha, MD
Sub-Investigator: Juan José García Guerrero, MD
H. Clínic i Provincial	Recruiting
Barcelona, Spain
Contact: Luis Mont, MD lmont@clinic.ub.es
Principal Investigator: Luis Mont, MD
H. Puerta de Hierro	Recruiting
Madrid, Spain, 28035
Contact: Ignacio Fernández Lozano, MD ifernandezl@sego.es
Principal Investigator: Ignacio Fernandez Lozano, MD
Sub-Investigator: Jorge Toquero, MD
H. C. U. Virgen de la Victoria	Recruiting
Málaga, Spain
Contact: Alberto Barrera, MD barreracordero@terra.es
Principal Investigator: Alberto Barrera

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

Medtronic Inc. This link exits the ClinicalTrials.gov site

Publications of Results:

Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices--summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). J Am Coll Cardiol. 2002 Nov 6;40(9):1703-19. No abstract available.

Sharpe N, Murphy J, Smith H, Hannan S. Treatment of patients with symptomless left ventricular dysfunction after myocardial infarction. Lancet. 1988 Feb 6;1(8580):255-9.

Navarro-Lopez F, de Teresa E, Lopez-Sendon JL, Castro-Beiras A. [Guidelines for the diagnosis and management of heart failure and cardiogenic shock. Informe del Grupo de Trabajo de Insuficiencia Carddiacade la Sociedad Espannola de Cardiologia] Rev Esp Cardiol. 1999;52 Suppl 2:1-54. Spanish.

Pfeffer MA, Lamas GA, Vaughan DE, Parisi AF, Braunwald E. Effect of captopril on progressive ventricular dilatation after anterior myocardial infarction. N Engl J Med. 1988 Jul 14;319(2):80-6.

Pfeffer MA, Braunwald E, Moye LA, Basta L, Brown EJ Jr, Cuddy TE, Davis BR, Geltman EM, Goldman S, Flaker GC, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. N Engl J Med. 1992 Sep 3;327(10):669-77.

[No authors listed] Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). The CONSENSUS Trial Study Group. N Engl J Med. 1987 Jun 4;316(23):1429-35.

FINNEY JO Jr. HEMODYNAMIC ALTERATIONS IN LEFT VENTRICULAR FUNCTION CONSEQUENT TO VENTRICULAR PACING. Am J Physiol. 1965 Feb;208:275-82. No abstract available.

Kappenberger L. Pacing for obstructive hypertrophic cardiomyopathy. Br Heart J. 1995 Feb;73(2):107. No abstract available.

Grover M, Glantz SA. Endocardial pacing site affects left ventricular end-diastolic volume and performance in the intact anesthetized dog. Circ Res. 1983 Jul;53(1):72-85.

Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.

Gras D, Mabo P, Tang T, Luttikuis O, Chatoor R, Pedersen AK, Tscheliessnigg HH, Deharo JC, Puglisi A, Silvestre J, Kimber S, Ross H, Ravazzi A, Paul V, Skehan D. Multisite pacing as a supplemental treatment of congestive heart failure: preliminary results of the Medtronic Inc. InSync Study. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 2):2249-55.

Cazeau S, Ritter P, Lazarus A, Gras D, Backdach H, Mundler O, Mugica J. Multisite pacing for end-stage heart failure: early experience. Pacing Clin Electrophysiol. 1996 Nov;19(11 Pt 2):1748-57.

Cazeau S, Ritter P, Bakdach S, Lazarus A, Limousin M, Henao L, Mundler O, Daubert JC, Mugica J. Four chamber pacing in dilated cardiomyopathy. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 2):1974-9.

Barold SS, Cazeau S. The first reports of electrical multisite ventricular activation in humans. Pacing Clin Electrophysiol. 2000 Dec;23(12):2117-9. No abstract available.

Grines CL, Bashore TM, Boudoulas H, Olson S, Shafer P, Wooley CF. Functional abnormalities in isolated left bundle branch block. The effect of interventricular asynchrony. Circulation. 1989 Apr;79(4):845-53.

Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. Epub 2003 Jun 02.

Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. Epub 2002 Mar 19.

Wilkoff BL; Dual Chamber and VVI Implantable Defibrillator trial investigators. The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial: rationale, design, results, clinical implications and lessons for future trials. Card Electrophysiol Rev. 2003 Dec;7(4):468-72.

Thackray SD, Witte KK, Nikitin NP, Clark AL, Kaye GC, Cleland JG. The prevalence of heart failure and asymptomatic left ventricular systolic dysfunction in a typical regional pacemaker population. Eur Heart J. 2003 Jun;24(12):1143-52.

Lamas GA, Lee K, Sweeney M, Leon A, Yee R, Ellenbogen K, Greer S, Wilber D, Silverman R, Marinchak R, Bernstein R, Mittleman RS, Lieberman EH, Sullivan C, Zorn L, Flaker G, Schron E, Orav EJ, Goldman L. The mode selection trial (MOST) in sinus node dysfunction: design, rationale, and baseline characteristics of the first 1000 patients. Am Heart J. 2000 Oct;140(4):541-51.

Tang AS, Roberts RS, Kerr C, Gillis AM, Green MS, Talajic M, Yusuf S, Abdollah H, Gent M, Connolly SJ. Relationship between pacemaker dependency and the effect of pacing mode on cardiovascular outcomes. Circulation. 2001 Jun 26;103(25):3081-5.

Study ID Numbers:	PreVent-HF
Study First Received:	September 13, 2005
Last Updated:	December 15, 2005
ClinicalTrials.gov Identifier:	NCT00170326
Health Authority:	Spain: Spanish Agency for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:

Permanent Pacing artificial internal

Study placed in the following topic categories:

Ventricular Dysfunction
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009