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

This study is currently recruiting participants.
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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 16, 2013