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

Primary Purpose

Cardiac Pacing Indication classI/IIa According AHA/ACC

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dual-chamber pacemaker implantation
biventricular dual-chamber pacemaker implant
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Pacing Indication classI/IIa According AHA/ACC focused on measuring Permanent Pacing artificial internal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General de Alicante
  • H. Infanta Cristina
  • H. Clínic i Provincial
  • H. Puerta de Hierro
  • H. C. U. Virgen de la Victoria

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dual Chamber pacing

Biventricular pacing

Arm Description

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

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

Outcomes

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 HF and hospitalization due to cardiovascular problems. Morbidity.

Full Information

First Posted
September 13, 2005
Last Updated
April 18, 2017
Sponsor
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00170326
Brief Title
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
Acronym
Prevent-HF
Official Title
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Pacing Indication classI/IIa According AHA/ACC
Keywords
Permanent Pacing artificial internal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Chamber pacing
Arm Type
Active Comparator
Arm Description
conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex
Arm Title
Biventricular pacing
Arm Type
Experimental
Arm Description
Biventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle
Intervention Type
Procedure
Intervention Name(s)
dual-chamber pacemaker implantation
Other Intervention Name(s)
DDD pacing, RV
Intervention Description
Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device.
Intervention Type
Procedure
Intervention Name(s)
biventricular dual-chamber pacemaker implant
Other Intervention Name(s)
InSync 8040, InSync III 8042
Intervention Description
Biventricular pacemaker system or in case in ICD indication a BIV ICD
Primary Outcome Measure Information:
Title
Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo De Teresa, MD
Organizational Affiliation
Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Alzueta, MD
Organizational Affiliation
Hospital Clinico Universitario Virgen de la Victoria, Málaga, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Fernández Lozano, MD
Organizational Affiliation
Hospital Puerta de Hierro, Madrid, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan José Gómez Doblas, MD
Organizational Affiliation
Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Navarro López, MD
Organizational Affiliation
Hospital Clinic i Provincial, Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. Curnis, MD
Organizational Affiliation
Ospedale Civile Brescia, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xavier Navarro Michel, MD
Organizational Affiliation
Medtronic Ibérica, S.A., Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Stockburger, MD
Organizational Affiliation
Charite, Campus Virchow-Klinikum, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gervasio Lamas, MD
Organizational Affiliation
Mount Sinai Clinical Center, Miami, FL, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
H. Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
H. Clínic i Provincial
City
Barcelona
Country
Spain
Facility Name
H. Puerta de Hierro
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
H. C. U. Virgen de la Victoria
City
Málaga
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17460018
Citation
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.
Results Reference
background
PubMed Identifier
21613427
Citation
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.
Results Reference
result
PubMed Identifier
23861381
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 from the PREVENT-HF German Substudy. Europace. 2014 Jan;16(1):63-70. doi: 10.1093/europace/eut217. Epub 2013 Jul 16.
Results Reference
result

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Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

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