Thromboembolic Complications After Pacemaker or Implantable Cardioverter-Defibrillator Procedures

Cardiovascular Disease Clinical Trial

Official title:

Thromboembolic Complications Associated With Pacemaker or Implantable Cardioverter-Defibrillator Procedures: a Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01717495
• Other study ID #: CAPPesq: 0730/11
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2012
• Last updated: May 4, 2013
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: Roberto Costa, MD PhD
• Phone: 55-11-2661
• Email: rcosta[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: April 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias
• Bradyarrhythmias
• Bradycardia
• Cardiovascular Disease
• Cardiovascular Diseases
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Duke University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Venous lesions	Venous stenosis (any degree) detected by subtraction venography	Participants will be evaluated at 12 months after the surgical procedure	No