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

November 5, 2012 updated by: Roberto Costa, University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Recruiting
        • Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
        • Sub-Investigator:
          • Silvana AD Nishioka, MD, PhD
        • Contact:
        • Principal Investigator:
          • Roberto Costa, MD, PhD
        • Sub-Investigator:
          • Katia R Silva, RN, PhD
        • Sub-Investigator:
          • Caio MM Albertini, MD
        • Sub-Investigator:
          • Martino Martinelli Filho, MD, PhD
        • Sub-Investigator:
          • Wagner T Tamaki, MD, PhD
        • Sub-Investigator:
          • Irapuan M Penteado, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: RV Pacing
Right ventricular pacing
Device: Right ventricular pacing (Medtronic)
Conventional right ventricular pacing in patients with bradycardia.
Other Names:
  • 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 Names:
  • Attain StarFix® Model 4195 OTW Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be evaluated at 6 and 24 months after PM implantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Participants will be evaluated at 6 and 24 months after PM implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

September 30, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (ESTIMATE)

October 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 00610412.2.0000.0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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