Cardiac Pacing Indication classI/IIa According AHA/ACCPrevent-HFNCT00170326
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
A study testing dual-chamber pacemaker implantation and biventricular dual-chamber pacemaker implant in people with Cardiac Pacing Indication classI/IIa According AHA/ACC, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing Indication classI/IIa According AHA/ACC
- What is being tested?
- dual-chamber pacemaker implantation and biventricular dual-chamber pacemaker implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesSpain
- Study dates
- Jan 2002to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital General de Alicante
Alicante
H. Infanta Cristina
Badajoz
H. Clínic i Provincial
Barcelona
H. Puerta de Hierro
Madrid, 28035
H. C. U. Virgen de la Victoria
Málaga
About this study
The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.
Read the 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.
- Being tested
- dual-chamber pacemaker implantation, biventricular dual-chamber pacemaker implant
- Keywords
- Permanent Pacing artificial internal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-chamber pacemaker implantationProcedure or surgery
Also called DDD pacing, RV
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 implantProcedure or surgery
Also called InSync 8040, InSync III 8042
Biventricular pacemaker system or in case in ICD indication a BIV ICD
| Study group | Role | What they receive |
|---|---|---|
| Dual Chamber pacing | Active comparator | conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex Receives: Procedure: dual-chamber pacemaker implantation |
| Biventricular pacing | Experimental | Biventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle Receives: Procedure: biventricular dual-chamber pacemaker implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.
Measured: 12 months
Secondary outcomes (1)
Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Pacing Indication classI/IIa According AHA/ACCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo De Teresa, MD, Principal investigator, Hospital Clínico Universitario Virgen de la Victoria, Málaga, SpainJavier Alzueta, MD, Principal investigator, Hospital Clinico Universitario Virgen de la Victoria, Málaga, SpainIgnacio Fernández Lozano, MD, Principal investigator, Hospital Puerta de Hierro, Madrid, SpainJuan José Gómez Doblas, MD, Principal investigator, Hospital Clínico Universitario Virgen de la Victoria, Málaga, SpainFrancisco Navarro López, MD, Principal investigator, Hospital Clinic i Provincial, Barcelona, SpainA. Curnis, MD, Principal investigator, Ospedale Civile Brescia, ItalyXavier Navarro Michel, MD, Principal investigator, Medtronic Ibérica, S.A., Barcelona, SpainM. Stockburger, MD, Principal investigator, Charite, Campus Virchow-Klinikum, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170326
- Sponsor's protocol ID
- PreVent-HF
- Acronym
- Prevent-HF
- Status last verified
- Apr 2017
- First submitted
- 13 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17460018Stockburger 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.
PubMed 21613427Stockburger 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.
PubMed 23861381
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
- ClinicalTrials.gov ID
- NCT00170326
- Acronym / sponsor ID
- Prevent-HF / PreVent-HF
- Keywords
- Permanent Pacing artificial internal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Chamber pacing | Active comparator | Procedure: dual-chamber pacemaker implantationconventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex |
| Biventricular pacing | Experimental | Procedure: biventricular dual-chamber pacemaker implantBiventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual-chamber pacemaker implantationAlso: DDD pacing, RVDual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device. | Procedure or surgery | Dual Chamber pacing |
| biventricular dual-chamber pacemaker implantAlso: InSync 8040, InSync III 8042Biventricular pacemaker system or in case in ICD indication a BIV ICD | Procedure or surgery | Biventricular pacing |
Primary outcome
Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.
Time frame: 12 months
1 secondary outcome
Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 17460018de 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 publication: PubMed 21613427Stockburger 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 publication: PubMed 23861381Stockburger 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo De Teresa, MD principal investigator
Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
Javier Alzueta, MD principal investigator
Hospital Clinico Universitario Virgen de la Victoria, Málaga, Spain
Ignacio Fernández Lozano, MD principal investigator
Hospital Puerta de Hierro, Madrid, Spain
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual-chamber pacemaker implantation and biventricular dual-chamber pacemaker implant in people with Cardiac Pacing Indication classI/IIa According AHA/ACC, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00170326, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.