A Phase 4 interventional study of Left ventricular pacing through coronary sinus tributaries (Attain StarFix) and Right ventricular pacing (Medtronic) in Bradyarrhythmias, Arrhythmias and Atrioventricular Block, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-11-06.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.
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.
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This study's planned enrollment of 12 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
Right ventricular pacing
Device: Right ventricular pacing (Medtronic)
Left ventricular pacing through coronary sinus tributaries
Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)
Left ventricular pacing in patients with bradycardia
Also known as: Attain StarFix® Model 4195 OTW Lead
Conventional right ventricular pacing in patients with bradycardia.
Also known as: Right ventricular lead Medtronic 5076-58
Surgical success
Surgical success: absence of complications
Time frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
Echocardiographic and Clinical composite
Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure
Time frame: Participants will be evaluated at 6 and 24 months after PM implantation
Quality of Life
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).
Time frame: Participants will be evaluated at 6 and 24 months after PM implantation
This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo