Ventricular TachycardiaNCT00335036
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
A study testing ICD lead implant and Thin leads in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Charles Berul at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 55 years
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy
- What is being tested?
- ICD lead implant and Thin leads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome, Congenital Heart Disease
- Being tested
- ICD lead implant, Thin leads
- Keywords
- Implantable Cardioverter Defibrillator, Ventricular Arrhythmia, Sudden Cardiac Death, Congenital Heart Disease, Pediatric Electrophysiology
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Cardiomyopathies, Long QT Syndrome, Heart Defects, Congenital, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD lead implantDevice
Randomization of ICD lead type at implant
Thin leadsDevice
Thin (less than or equal to 7 French introducer) isodiametric ICD leads
| Study group | Role | What they receive |
|---|---|---|
| Thin leads | Active comparator | Thin (less than or equal to 7 French introducer) isodiametric ICD leads Receives: Device: Thin leads |
| Gore PTFE-coated | Active comparator | ICD lead with PTFE-coated coils Receives: Device: ICD lead implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD Lead Functionality and Performance by Subtype
Lead survival
Measured: 5 years
Compare Ease of Lead Extractability by Subtype
Extraction techniques include simple traction (no locking stylet or sheath) and advanced extraction (locking stylet with a sheath). Compared number of extractions using each technique for single and ePTFE-coated coils.
Measured: 5 years
Secondary outcomes (2)
Number of Patients With Major Complications
Major complications experienced by patients undergoing lead extraction.
Measured: 5 years
Comparison of Inappropriate Shocks
Comparison of inappropriate shocks between thin leads and PTFE-coated leads.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Lead was recalled and manufacturing halted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Berul
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Guidant Corporation
- Responsible party
- Sponsor-investigator, Charles Berul, Children's National Research Institute
- Investigators
- Charles I Berul, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335036
- Sponsor's protocol ID
- CHB-05-11-147
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2006
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Alexander ME, Cecchin F, Walsh EP, Triedman JK, Bevilacqua LM, Berul CI. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol. 2004 Jan;15(1):72-6. doi: 10.1046/j.1540-8167.2004.03388.x.
PubMed 15028076Stephenson EA, Batra AS, Knilans TK, Gow RM, Gradaus R, Balaji S, Dubin AM, Rhee EK, Ro PS, Thogersen AM, Cecchin F, Triedman JK, Walsh EP, Berul CI. A multicenter experience with novel implantable cardioverter defibrillator configurations in the pediatric and congenital heart disease population. J Cardiovasc Electrophysiol. 2006 Jan;17(1):41-6. doi: 10.1111/j.1540-8167.2005.00271.x.
PubMed 16426398Cooper JM, Stephenson EA, Berul CI, Walsh EP, Epstein LM. Implantable cardioverter defibrillator lead complications and laser extraction in children and young adults with congenital heart disease: implications for implantation and management. J Cardiovasc Electrophysiol. 2003 Apr;14(4):344-9. doi: 10.1046/j.1540-8167.2003.02500.x.
PubMed 12741703Link MS, Hill SL, Cliff DL, Swygman CA, Foote CB, Homoud MK, Wang PJ, Estes NA 3rd, Berul CI. Comparison of frequency of complications of implantable cardioverter-defibrillators in children versus adults. Am J Cardiol. 1999 Jan 15;83(2):263-6, A5-6. doi: 10.1016/s0002-9149(98)00834-0.
PubMed 10073833Atallah J, Erickson CC, Cecchin F, Dubin AM, Law IH, Cohen MI, Lapage MJ, Cannon BC, Chun TU, Freedenberg V, Gierdalski M, Berul CI; Pediatric and Congenital Electrophysiology Society (PACES). Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study. Circulation. 2013 Jun 18;127(24):2393-402. doi: 10.1161/CIRCULATIONAHA.112.001120. Epub 2013 May 21.
PubMed 23694966
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00335036
- Acronym / sponsor ID
- CHB-05-11-147
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome, Congenital Heart Disease
- Keywords
- Implantable Cardioverter Defibrillator, Ventricular Arrhythmia, Sudden Cardiac Death, Congenital Heart Disease, Pediatric Electrophysiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lead was recalled and manufacturing halted
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Charles BerulUniversity, hospital or other
- Collaborators
- Medtronic, Guidant Corporation
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Jun 2006 (estimated)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin leads | Active comparator | Device: Thin leadsThin (less than or equal to 7 French introducer) isodiametric ICD leads |
| Gore PTFE-coated | Active comparator | Device: ICD lead implantICD lead with PTFE-coated coils |
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD lead implantRandomization of ICD lead type at implant | Device | Gore PTFE-coated |
| Thin leadsThin (less than or equal to 7 French introducer) isodiametric ICD leads | Device | Thin leads |
Primary outcome
ICD Lead Functionality and Performance by Subtype
Time frame: 5 years
Lead survival
Compare Ease of Lead Extractability by Subtype
Time frame: 5 years
Extraction techniques include simple traction (no locking stylet or sheath) and advanced extraction (locking stylet with a sheath). Compared number of extractions using each technique for single and ePTFE-coated coils.
2 secondary outcomes
Number of Patients With Major Complications
Time frame: 5 years
Comparison of Inappropriate Shocks
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15028076Alexander ME, Cecchin F, Walsh EP, Triedman JK, Bevilacqua LM, Berul CI. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol. 2004 Jan;15(1):72-6. doi: 10.1046/j.1540-8167.2004.03388.x.
- Background: PubMed 16426398Stephenson EA, Batra AS, Knilans TK, Gow RM, Gradaus R, Balaji S, Dubin AM, Rhee EK, Ro PS, Thogersen AM, Cecchin F, Triedman JK, Walsh EP, Berul CI. A multicenter experience with novel implantable cardioverter defibrillator configurations in the pediatric and congenital heart disease population. J Cardiovasc Electrophysiol. 2006 Jan;17(1):41-6. doi: 10.1111/j.1540-8167.2005.00271.x.
- Background: PubMed 12741703Cooper JM, Stephenson EA, Berul CI, Walsh EP, Epstein LM. Implantable cardioverter defibrillator lead complications and laser extraction in children and young adults with congenital heart disease: implications for implantation and management. J Cardiovasc Electrophysiol. 2003 Apr;14(4):344-9. doi: 10.1046/j.1540-8167.2003.02500.x.
- Background: PubMed 10073833Link MS, Hill SL, Cliff DL, Swygman CA, Foote CB, Homoud MK, Wang PJ, Estes NA 3rd, Berul CI. Comparison of frequency of complications of implantable cardioverter-defibrillators in children versus adults. Am J Cardiol. 1999 Jan 15;83(2):263-6, A5-6. doi: 10.1016/s0002-9149(98)00834-0.
- Derived from this study: PubMed 23694966Atallah J, Erickson CC, Cecchin F, Dubin AM, Law IH, Cohen MI, Lapage MJ, Cannon BC, Chun TU, Freedenberg V, Gierdalski M, Berul CI; Pediatric and Congenital Electrophysiology Society (PACES). Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study. Circulation. 2013 Jun 18;127(24):2393-402. doi: 10.1161/CIRCULATIONAHA.112.001120. Epub 2013 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles I Berul, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD lead implant and Thin leads in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Charles Berul at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICD Lead Functionality and Performance by Subtype (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335036, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.