Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias (SAFE-LVPACE)
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|ClinicalTrials.gov Identifier: NCT01717469|
Recruitment Status : Unknown
Verified November 2012 by Roberto Costa, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : October 30, 2012
Last Update Posted : November 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bradyarrhythmias Arrhythmias Atrioventricular Block Ventricular Dysfunction Cardiovascular Disease||Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix) Device: Right ventricular pacing (Medtronic)||Phase 4|
Over the past several years, there has been growing concern over the significant deleterious effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development of heart failure (HF). However, it remains unclear whether pacing-related ventricular dyssynchrony can translate into significant LV structural changes and produce important clinical impairment in an average pacemaker population with compromised AV conduction. Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony and to improve symptoms and prognosis in patients with mild to moderated systolic HF and prolonged QRS duration.
This randomized controlled study is been conducted to compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The hypothesis is that isolated LV pacing through the coronary sinus can be used safely and provide greater hemodynamic benefits to patients with AV block and normal ventricular function who require only the correction of heart rate.
Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of left ventricular pacing using active-fixation coronary sinus lead—the Attain StarFix® Model 4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria for conventional pacemaker stimulation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2017|
Active Comparator: RV Pacing
Right ventricular pacing
Device: Right ventricular pacing (Medtronic)
Conventional right ventricular pacing in patients with bradycardia.
Other Name: Right ventricular lead Medtronic 5076-58
Experimental: LV Pacing
Left ventricular pacing through coronary sinus tributaries
Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)
Left ventricular pacing in patients with bradycardia
Other Name: Attain StarFix® Model 4195 OTW Lead
- Surgical success [ Time Frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days ]Surgical success: absence of complications
- Echocardiographic and Clinical composite [ Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation ]Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure
- Quality of Life [ Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation ]Quality of life: improvement on quality of life scores measured by three questionnaires: 36-Item Short Form Health Survey (SF-36), a disease specific questionnaire for pacemaker patients (Aquarel) and Minnesota Living With Heart Failure (MLWHF).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717469
|Contact: Roberto Costa, MD PhD||55-11-2661 ext firstname.lastname@example.org|
|Contact: Katia R Silva, RN PhDemail@example.com|
|Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo||Recruiting|
|Sao Paulo, Brazil, 05403-900|
|Contact: Robeto Costa, MD PhD 55-11-2661 ext 5284 firstname.lastname@example.org|
|Contact: Katia R Silva, RN PhD 9195978619 email@example.com|
|Principal Investigator: Roberto Costa, MD, PhD|
|Sub-Investigator: Elizabeth S Crevelari, MD|
|Sub-Investigator: Katia R Silva, RN, PhD|
|Sub-Investigator: Caio MM Albertini, MD|
|Sub-Investigator: Marianna S Lacerda, RN|
|Sub-Investigator: Martino Martinelli Filho, MD, PhD|
|Sub-Investigator: Wagner T Tamaki, MD, PhD|
|Sub-Investigator: Roberto M Oliveira Jr, MD|
|Sub-Investigator: Wilson Mathias Jr, MD, PhD|
|Sub-Investigator: Silvana AD Nishioka, MD, PhD|
|Sub-Investigator: Irapuan M Penteado, MD|
|Principal Investigator:||Roberto Costa, MD PhD||University of Sao Paulo|