Trial Outcomes & Findings for Pediatric Lead Extractability and Survival Evaluation (PLEASE) (NCT NCT00335036)

NCT ID: NCT00335036

Last Updated: 2025-07-17

Results Overview

Lead survival

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 748 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2025-07-17

Participant Flow

Participant milestones

Measure	Thin Leads Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
Overall Study STARTED	525	223
Overall Study COMPLETED	525	223
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Thin Leads n=525 Participants Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=223 Participants ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant	Total n=748 Participants Total of all reporting groups
Age, Categorical <=18 years	384 Participants n=525 Participants	112 Participants n=223 Participants	496 Participants n=748 Participants
Age, Categorical Between 18 and 65 years	141 Participants n=525 Participants	111 Participants n=223 Participants	252 Participants n=748 Participants
Age, Categorical >=65 years	0 Participants n=525 Participants	0 Participants n=223 Participants	0 Participants n=748 Participants
Age, Continuous	17.9 years STANDARD_DEVIATION 10.6 • n=525 Participants	18.8 years STANDARD_DEVIATION 9.6 • n=223 Participants	18.6 years STANDARD_DEVIATION 9.8 • n=748 Participants
Sex: Female, Male Female	245 Participants n=525 Participants	103 Participants n=223 Participants	348 Participants n=748 Participants
Sex: Female, Male Male	280 Participants n=525 Participants	120 Participants n=223 Participants	400 Participants n=748 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	525 participants n=525 Participants	223 participants n=223 Participants	748 participants n=748 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Intent to compare the survival of thin leads versus PTFE-coated coils.

Lead survival

Outcome measures

Measure	Thin Leads n=525 Participants Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=223 Participants ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
ICD Lead Functionality and Performance by Subtype	55 percentage of leads to 5 years Interval 52.0 to 60.0	92 percentage of leads to 5 years Interval 88.0 to 94.0

PRIMARY outcome

Timeframe: 5 years

Population: Intent to compare the ease of extraction of isodiametric ICD leads versus ICD leads with PTFE-coated coils.

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.

Outcome measures

Measure	Thin Leads n=114 Participants Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=23 Participants ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
Compare Ease of Lead Extractability by Subtype	53 Participants	12 Participants

SECONDARY outcome

Timeframe: 5 years

Major complications experienced by patients undergoing lead extraction.

Outcome measures

Measure	Thin Leads n=127 Participants Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=10 Participants ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
Number of Patients With Major Complications	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 5 years

Comparison of inappropriate shocks between thin leads and PTFE-coated leads.

Outcome measures

Measure	Thin Leads n=300 Participants Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=223 Participants ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
Comparison of Inappropriate Shocks	33 Participants	13 Participants

Adverse Events

Thin Leads

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Gore PTFE-coated

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Thin Leads n=525 participants at risk Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=223 participants at risk ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
Cardiac disorders Advanced Lead Extraction	0.95% 5/525 • Number of events 5	0.45% 1/223 • Number of events 1

Other adverse events

Measure	Thin Leads n=525 participants at risk Thin (less than or equal to 7 French introducer) isodiametric ICD leads Thin leads: Thin (less than or equal to 7 French introducer) isodiametric ICD leads	Gore PTFE-coated n=223 participants at risk ICD lead with PTFE-coated coils ICD lead implant: Randomization of ICD lead type at implant
Cardiac disorders Inappropriate Shocks	7.4% 39/525 • Number of events 39	6.3% 14/223 • Number of events 14

Additional Information

Charles Berul, MD

Children's National

Phone: 202-476-5710

Email: cberul@childrensnational.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place