Clinical trial NCT01717469: Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Official title: Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bradyarrhythmias
Arrhythmias
Atrioventricular Block
Ventricular Dysfunction
Cardiovascular Disease
Keywords: Pacemaker
Pacemaker implantation
Coronary sinus
Ventricular dysfunction
Right ventricular pacing
Left ventricular pacing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2012-10-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Pacemaker initial implant by transvenous approach
* Presence of AV block
* Presence of atrial fibrillation / atrial flutter with slow ventricular response
* Left ventricular systolic function \> 0.40
* Subject agreed to participate and signed the consent form

Exclusion Criteria:

* Absence of venous access
* Impediment of venous access due to presence of intracardiac defects
* Impediment of venous access due to presence of tricuspid valve prosthesis
* Need for radiotherapy in the chest
* Presence of chest deformity
* Pregnancy
* Life expectancy of less than one year
* Contraindication to administration of iodinated contrast (creatinine \> 3.0) Unable to attend the follow-up appointments

Primary outcomes:
measure: Surgical success
timeFrame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
Secondary outcomes:
measure: Echocardiographic and Clinical composite
timeFrame: Participants will be evaluated at 6 and 24 months after PM implantation
Other outcomes:
measure: Quality of Life
timeFrame: Participants will be evaluated at 6 and 24 months after PM implantation
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Roberto Costa, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: