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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. 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).

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Roberto Costa, MD PhD	55-11-2661 ext 5284	rcosta@incor.usp.br
Contact: Katia R Silva, RN PhD	9195978619	katia.research@gmail.com

Locations

Brazil
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 rcosta@gmail.com
Contact: Katia R Silva, RN PhD 9195978619 katia.research@gmail.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

Sponsors and Collaborators

University of Sao Paulo

Duke University

Investigators

Principal Investigator:	Roberto Costa, MD PhD	University of Sao Paulo

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Roberto Costa, Associated Professor of Cardiovascular Surgery, MD PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01717469 History of Changes
Other Study ID Numbers:	CAAE 00610412.2.0000.0068
First Posted:	October 30, 2012
Last Update Posted:	November 6, 2012
Last Verified:	November 2012

Keywords provided by Roberto Costa, University of Sao Paulo:

Pacemaker; Pacemaker implantation; Coronary sinus	Ventricular dysfunction; Right ventricular pacing; Left ventricular pacing

Additional relevant MeSH terms:

Cardiovascular Diseases; Ventricular Dysfunction; Atrioventricular Block; Bradycardia	Heart Diseases; Heart Block; Arrhythmias, Cardiac; Pathologic Processes