Safety & the Effects of Isolated Left Ventricular Pacing in Patients With

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01717469
Study type	Interventional
Source	University of Sao Paulo
Contact	Roberto Costa, MD PhD
Phone	55-11-2661
Email	rcosta@incor.usp.br
Status	Recruiting
Phase	Phase 4
Start date	June 2012
Completion date	June 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02122198` - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women	N/A
Completed	`NCT02502812` - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects	Phase 1
Recruiting	`NCT04216342` - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers	Phase 1
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT03646656` - Heart Health Buddies: Peer Support to Decrease CVD Risk	N/A
Completed	`NCT02081066` - Identification of CETP as a Marker of Atherosclerosis	N/A
Completed	`NCT02147626` - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia	N/A
Not yet recruiting	`NCT06405880` - Pharmacist Case Finding and Intervention for Vascular Prevention Trial	N/A
Recruiting	`NCT03095261` - Incentives in Cardiac Rehabilitation	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Completed	`NCT02589769` - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons	N/A
Completed	`NCT02711878` - Healing Hearts and Mending Minds in Older Adults Living With HIV	N/A
Completed	`NCT02868710` - Individual Variability to Aerobic Exercise Training	N/A
Recruiting	`NCT02885792` - Coronary Artery Disease in Patients Suffering From Schizophrenia	N/A
Completed	`NCT02657382` - Mental Stress Ischemia: Biofeedback Study	N/A
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A
Completed	`NCT02640859` - Investigation of Metabolic Risk in Korean Adults
Completed	`NCT02272946` - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk	Phase 2
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias — SAFE-LVPACE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms