Pediatric Lead Extractability and Survival Evaluation (PLEASE)

This study has been terminated.
(Lead was recalled and manufacturing halted)
Sponsor:
Collaborators:
Medtronic
Guidant Corporation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00335036
First received: June 6, 2006
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease. ICD lead survival in this patient group is particularly suboptimal, and lead extraction is technically difficult and carries a substantial morbidity risk. Recently, improved ICD lead designs have been released and are currently being utilized in patients. The main aim of the study is to determine if either type of lead performs better in terms of implantation electrical characteristics, long-term survival without breaking, and ease of extractability.


Condition Intervention Phase
Ventricular Tachycardia
Ventricular Fibrillation
Cardiomyopathy
Long QT Syndrome
Congenital Heart Disease
Device: ICD lead implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pediatric Lead Extractability and Survival Evaluation (PLEASE)Study: A Prospective Assessment of Implantable Cardioverter Defibrillator (ICD) Lead Extractability and Survival in Children and Congenital Heart Disease Patients

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • ICD lead functionality and performance by subtype [ Time Frame: 5 years ]
  • Lead extractability by subtype [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Comparison of implant electrical parameters [ Time Frame: 5 years ]
  • Patient morbidity and mortality [ Time Frame: 5 years ]
  • Comparing each new lead type with each other and against historical pediatric controls with standard transvenous ICD leads [ Time Frame: 5 years ]
  • Comparison of inappropriate shocks [ Time Frame: 5 years ]

Enrollment: 55
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thin leads
Thin (less than or equal to 7 French introducer) isodiametric ICD leads
Device: ICD lead implant
Randomization of ICD lead type at implant
Active Comparator: Gore PTFE-coated
ICD lead with PTFE-coated coils
Device: ICD lead implant
Randomization of ICD lead type at implant

Detailed Description:

The recognition that ICD therapy in children can be life-saving, as well as the development of smaller devices and leads, are resulting in increased ICD implantation in the pediatric and young adult populations. However, ICD lead survival in this patient group is suboptimal. Lead extraction is technically difficult and has substantial morbidity. Recently, improved ICD lead designs have been released and are currently being utilized. While the development of transvenous ICD leads has allowed for less invasive implantation, the long-term presence of these leads carries some risks. When a lead becomes infected or causes patient morbidity, it must be removed. Because of the larger caliber of ICD leads and the presence of uninsulated shocking coils, non-functional ICD leads usually warrant removal to avoid future mechanical or electrical lead interactions. The larger size of ICD leads is of concern in this younger population, particularly with regard to avoiding the accumulation of implanted hardware. The principal indication for lead revision in children and young adults is lead malfunction, commonly related to patient growth and increased physical activity in this younger population. The removal of chronic indwelling pacer or ICD leads is not trivial. Scar tissue begins to bind transvenous leads to the endothelial surface several weeks after implantation, and this fibrous adherence progresses over time, exacerbated by high-energy shock delivery. In children and younger adult ICD recipients, exuberant lead scarring is prevalent, particularly in the regions of venous entry, high voltage shocking coils, and the lead tip. Transvenous lead extraction has been facilitated by the use of telescoping sheaths and powered sheaths that can be advanced over the lead to disrupt scar tissue and free the lead from the endothelium.

The 2 ICD lead types to be compared (thin ICD leads versus ePTFE-coated leads) in the proposed study are at clinical equipoise. Both types are believed to be improved over prior generation ICD leads. However, a direct comparison has not been performed. As the pediatric and congenital heart disease patient subgroup is younger than the average ICD patient population, they will have greater likelihood of long-term survival, and therefore, the issues of lead survival, durability, and extractability are critically important. While these themes are important for all ICD patients, they are particularly germane for younger patients who have more active lifestyles and are, in general, expected to outlive their ICD leads.

This study will prospectively assess the improvements in ICD lead design, specifically comparing a Gore ePTFE coating and thinner caliber ICD leads in pediatric and congenital heart disease population.

Specific Aim #1: To prospectively evaluate the long-term performance of modern-generation ICD leads in pediatric and congenital heart disease patients.

Specific Aim #2: To determine the potential beneficial effects of two improvements in ICD lead design - Gore ePTFE coil coating and thinner lead diameter in pediatric and congenital heart disease patients.

Specific Aim #3: To directly compare the safety and efficacy of these new ICD lead technologies in terms of extractability in pediatric and congenital heart disease patients.

The primary hypothesis is that improved lead designs and smaller diameter leads will demonstrate benefit in survival and extractability. The primary outcome variables will include: a) ICD lead functionality and performance by subtype, b) inappropriate shocks due to lead issues, c) lead extractability by subtype (Gore-coated versus thin leads).

Secondary outcomes include comparison of implant electrical parameters, patient morbidity and mortality, comparing each new lead type with each other and against historical pediatric controls with standard transvenous ICD leads.

  Eligibility

Ages Eligible for Study:   1 Year to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be eligible for study enrollment at the time of implantation of a new ICD and transvenous ICD lead.
  • All patients under the age of 21 years at the time of initial ICD implantation, or those patients with congenital heart disease and an indication for ICD implantation are eligible for participation.

Exclusion Criteria:

  • Patients who have existing ICD leads in place.
  • Patients with expected survival less than 1 year.
  • Patients who cannot be expected to participate in follow-up visits.
  • Patients receiving an epicardial or subcutaneous ICD (without transvenous ICD lead).
  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: NCT00335036

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Medtronic
Guidant Corporation
Investigators
Principal Investigator: Charles I Berul, MD Children's Hospital Boston
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00335036     History of Changes
Other Study ID Numbers: CHB-05-11-147
Study First Received: June 6, 2006
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Implantable Cardioverter Defibrillator
Ventricular Arrhythmia
Sudden Cardiac Death
Congenital Heart Disease
Pediatric Electrophysiology

Additional relevant MeSH terms:
Long QT Syndrome
Heart Diseases
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Heart Defects, Congenital
Cardiomyopathies
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014