Thromboembolic Complications After Pacemaker or Implantable Cardioverter-Defibrillator Procedures

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Sao Paulo
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Roberto Costa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01717495
First received: September 30, 2012
Last updated: May 4, 2013
Last verified: May 2013
  Purpose

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.


Condition
Bradyarrhythmias
Arrhythmias
Cardiovascular Disease
Venous Thrombosis
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboembolic Complications Associated With Pacemaker or Implantable Cardioverter-Defibrillator Procedures: a Prospective Registry

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Thromboembolic complications [ Time Frame: Participants will be evaluated at 1, 6, 12 months after the surgical procedure ] [ Designated as safety issue: Yes ]
    Upper extremity deep venous thrombosis Pulmonary embolism All cause mortality


Secondary Outcome Measures:
  • Venous lesions [ Time Frame: Participants will be evaluated at 12 months after the surgical procedure ] [ Designated as safety issue: No ]
    Venous stenosis (any degree) detected by subtraction venography


Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 1
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

More than 235.500 cardiac pacemakers and cardioverter-defibrillators are implanted in the US every year, with an estimated 25,000 new implants in Brazil. Despite its proven clinical effectiveness and efficacy for a number of clinical conditions such as arrhythmias, the number of adverse events in the post-implant period remains substantial. Among these complications, venous obstructions occurs anywhere between 14% and 64% of all patients, causing devastating consequences such as upper extremity deep venous thrombosis and pulmonary embolism, ultimately leading to either significant impairment or death. Although retrospective studies have demonstrated the high incidence of these complications, as a consequence of a paucity of reliable registries we know next to nothing regarding how these venous lesions may influence the clinical outcome and mortality of patients, whether laboratorial markers may contribute to the early diagnosis of venous thrombosis and its complications, and about properties of diagnostic imaging for the identification of thromboembolic complications after permanent transvenous leads implantation.

The objective of this study is therefore to propose a significant improvement in an existing clinical database located within the Heart Institute (INCOR) at the University of Sao Paulo to enable the provision of answers to a clinical, biomarker, and imaging-related research questions. Specifically, our aims are to:

  • Aim 1 - Registry infrastructure: In collaboration with professors from Duke University, we will create a series of improvements to the current database to enable it to serve as a platform not only for the current studies but also for future longitudinal, randomized studies. These include the standardization of variables in accordance with international guidelines, increase in patient retention and the ability to have additional data points in-between clinical appointments, improvement in the determination of cause of mortality, data quality monitoring, the creation of an item bank to measure aspects of quality of life that are specific for this population, as well as the integration of images and biomarkers to the clinical database.
  • Aim 2 - Diagnostic imaging methods: To identify the incidence of upper extremity deep venous thrombosis after cardiac devices implantations or reoperation procedures, as well, the incidence of symptomatic and asymptomatic pulmonary thromboembolism.
  • Aim 3 - Prognostic clinical factors: To study the impact of thromboembolic complications in the clinical prognostic and mortality of patients;
  • Aim 4 - Prognostic biomarkers: To determine the association between the biomarkers related with alterations in the hemostasis system and the occurrence of venous thrombosis (biomarkers: Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2, thromboxane B, Platelets, Plasminogen)

At the end of this study we will have a registry with one of the largest number of patients with this condition around the world, fully equipped for future randomized controlled trials. We will also have a much better understanding regarding clinical, imaging, and biomarkers for this condition.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01717495

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
São Paulo, Brazil, 05403-900
Contact: Katia R Silva, RN PhD    55-11-2661 ext 5284    katia.regina@incor.usp.br   
Principal Investigator: Roberto Costa, MD PhD         
Principal Investigator: Katia R Silva, RN PhD         
Sub-Investigator: Martino Martinelli Filho, MD PhD         
Sub-Investigator: Mario Terra Filho, MD PhD         
Sub-Investigator: Wilson Mathias Jr, MD PhD         
Sub-Investigator: Marta F Lima, MD PhD         
Sub-Investigator: Roberto A Rached, MD PhD         
Sub-Investigator: Claudio L Lucarelli, MD PhD         
Sub-Investigator: Francisco C Carnevale, MD PhD         
Sub-Investigator: Airton M Moreira, MD PhD         
Sub-Investigator: Wagner T Tamaki, MD PhD         
Sub-Investigator: Elizabeth S Crevelari, MD         
Sub-Investigator: Roberto M Oliveira Jr, MD         
Sub-Investigator: Marianna S Lacerda, RN         
Sponsors and Collaborators
University of Sao Paulo
Duke University
Investigators
Principal Investigator: Roberto Costa, MD PhD University of Sao Paulo
Principal Investigator: Katia R Silva, RN 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: NCT01717495     History of Changes
Other Study ID Numbers: CAPPesq: 0730/11
Study First Received: September 30, 2012
Last Updated: May 4, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Pacemaker
Implantable-cardioverter defibrillator
Cardiac Pacing, Artificial/adverse effects
Venous thrombosis
Pulmonary embolism
Phlebography
Biological markers
Computed tomography angiography

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Bradycardia
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism

ClinicalTrials.gov processed this record on July 10, 2014