Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias

Cardiovascular Disease Clinical Trial

— SAFE-LVPACE  

Official title:

Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01717469
• Other study ID #: CAAE 00610412.2.0000.0068
• Status: Recruiting
• Phase: Phase 4
• First received: September 30, 2012
• Last updated: November 5, 2012
• Start date: June 2012
• Est. completion date: June 2017

Study information

• Verified date: November 2012
• Source: University of Sao Paulo
• Contact: Roberto Costa, MD PhD
• Phone: 55-11-2661
• Email: rcosta[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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

• Arrhythmias
• Atrioventricular Block
• Bradyarrhythmias
• Bradycardia
• Cardiovascular Disease
• Cardiovascular Diseases
• Ventricular Dysfunction

Intervention

Device:
• Left ventricular pacing through coronary sinus tributaries (Attain StarFix)
Left ventricular pacing in patients with bradycardia
• Right ventricular pacing (Medtronic)
Conventional right ventricular pacing in patients with bradycardia.

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Duke University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Participants will be evaluated at 6 and 24 months after PM implantation	No
Primary	Surgical success	Surgical success: absence of complications	Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days	Yes
Secondary	Echocardiographic and Clinical composite	Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure	Participants will be evaluated at 6 and 24 months after PM implantation	Yes