NCT01717495

Brief Summary

This is a large prospective registry of patients submitted to cardiac electronic devices implantation designed to investigate the incidence, risk factors and prognostic of thromboembolic complications associated with transvenous lead implantation.

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
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

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

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
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

September 30, 2012

Last Update Submit

May 4, 2013

Conditions

BradyarrhythmiasArrhythmiasCardiovascular DiseaseVenous ThrombosisPulmonary Embolism

Keywords

PacemakerImplantable-cardioverter defibrillatorCardiac Pacing, Artificial/adverse effectsVenous thrombosisPulmonary embolismPhlebographyBiological markersComputed tomography angiography

Outcome Measures

Primary Outcomes (1)

  • Thromboembolic complications

    Upper extremity deep venous thrombosis Pulmonary embolism All cause mortality

    Participants will be evaluated at 1, 6, 12 months after the surgical procedure

Secondary Outcomes (1)

  • Venous lesions

    Participants will be evaluated at 12 months after the surgical procedure

Study Arms (2)

Implantation Procedures

Patients submitted to initial pacemaker or ICD implantation

Reoperation Procedures

Patients submitted to pacemaker or implantable cardioverter-defibrillator generator replacements, upgrade procedures and lead extraction

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients

You may qualify if:

  • Older than 18 years
  • Pacemaker/ implantable-cardioverter defibrillator (ICD) / cardiac resynchronization therapy (CRT) initial implant by transvenous approach or
  • Patients submitted to reoperation procedures, as: pulse generator replacement, implant of an additional lead, lead extraction, lead repositioning;
  • Subject agreed to participate and signed the consent form

You may not qualify if:

  • Patients with a history of venous thromboembolism, coagulopathy or malignancy
  • 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2, thromboxane B, Platelets, Plasminogen

MeSH Terms

Conditions

BradycardiaArrhythmias, CardiacCardiovascular DiseasesVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

Heart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Roberto Costa, MD PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Katia R Silva, RN 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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
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

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2016

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

BR(1)