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The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Chamber pacing | Active Comparator | conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex |
|
| Biventricular pacing | Experimental | Biventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual-chamber pacemaker implantation | Procedure | Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Alicante | Alicante | Spain | ||||
| H. Infanta Cristina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17460018 | Background | 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. | |
| 21613427 |
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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.
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| biventricular dual-chamber pacemaker implant | Procedure | Biventricular pacemaker system or in case in ICD indication a BIV ICD |
|
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| Principal Investigator |
| Badajoz |
| Spain |
| H. Clínic i Provincial | Barcelona | Spain |
| H. Puerta de Hierro | Madrid | 28035 | Spain |
| H. C. U. Virgen de la Victoria | Málaga | Spain |
| 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. |
| 23861381 | Result | 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. |