NCT01717469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

September 30, 2012

Last Update Submit

November 5, 2012

Conditions

BradyarrhythmiasArrhythmiasAtrioventricular BlockVentricular DysfunctionCardiovascular Disease

Keywords

PacemakerPacemaker implantationCoronary sinusVentricular dysfunctionRight ventricular pacingLeft ventricular pacing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Echocardiographic and Clinical composite

    Participants will be evaluated at 6 and 24 months after PM implantation

Other Outcomes (1)

  • Quality of Life

    Participants will be evaluated at 6 and 24 months after PM implantation

Study Arms (2)

RV Pacing

ACTIVE COMPARATOR

Right ventricular pacing

Device: Right ventricular pacing (Medtronic)

LV Pacing

EXPERIMENTAL

Left ventricular pacing through coronary sinus tributaries

Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)

Interventions

Left ventricular pacing through coronary sinus tributaries (Attain StarFix)DEVICE

Left ventricular pacing in patients with bradycardia

Also known as: Attain StarFix® Model 4195 OTW Lead
LV Pacing
Right ventricular pacing (Medtronic)DEVICE

Conventional right ventricular pacing in patients with bradycardia.

Also known as: Right ventricular lead Medtronic 5076-58
RV Pacing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

BradycardiaArrhythmias, CardiacAtrioventricular BlockVentricular DysfunctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Officials

  • Roberto Costa, MD PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Costa, MD PhD

CONTACT

55-11-2661rcosta@incor.usp.br

Katia R Silva, RN PhD

CONTACT

9195978619katia.research@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor of Cardiovascular Surgery, MD PhD

Study Record Dates

First Submitted

September 30, 2012

First Posted

October 30, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2017

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

BR(1)