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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2012 by University of Sao Paulo

Sponsor:

Collaborator:

Duke University

Information provided by (Responsible Party):

Roberto Costa, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01717469

First received: September 30, 2012

Last updated: November 5, 2012

Last verified: November 2012

History of Changes

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Surgical success [ Time Frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days ] [ Designated as safety issue: Yes ]
Surgical success: absence of complications

Secondary Outcome Measures:

Echocardiographic and Clinical composite [ Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation ] [ Designated as safety issue: Yes ]
Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure

Other Outcome Measures:

Quality of Life [ Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation ] [ Designated as safety issue: No ]
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).


Estimated Enrollment:	12
Study Start Date:	June 2012
Estimated Study Completion Date:	June 2017
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717469

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

No publications provided


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
Study First Received:	September 30, 2012
Last Updated:	November 5, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015

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