Trial Outcomes & Findings for Human Use Condition Study- Evaluation of Implanted Leads in Humans (NCT NCT04320849)

NCT ID: NCT04320849

Last Updated: 2024-01-19

Results Overview

Measure dynamic in vivo curvature of RV pacing and defibrillator leads in the extravenous and intracardiac anatomy \*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the extravenous region will be determined during specified arm movements. The relationship between lead stiffness and curvature will be evaluated.

Recruitment status

COMPLETED

Target enrollment

117 participants

Primary outcome timeframe

Approximately 1 month

Results posted on

2024-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Consented Patients With RV Pacing Leads and Defibrillation Leads Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane)
Overall Study STARTED	117
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Consented Patients With RV Pacing Leads and Defibrillation Leads Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane)
Overall Study Withdrawal by Subject	4
Overall Study Imaging data unavailable	2
Overall Study Incomplete imaging	2

Baseline Characteristics

Human Use Condition Study- Evaluation of Implanted Leads in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Consented Patients With RV Pacing Leads and Defibrillation Leads n=117 Participants Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Number of Leads Imaged: 21 Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Number of Leads Imaged: 27 Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Number of Leads Imaged: 23 Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Number of Leads Imaged: 1 Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Number of Leads Imaged: 31
Age, Continuous	68.72 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 1 month

Population: Consented patients with imaging data.

Outcome measures

Outcome measures
Measure	Consented Patients With RV Pacing Leads and Defibrillation Leads n=109 Participants Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane)
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements	109 Participants

PRIMARY outcome

Timeframe: Approximately 1 month

Population: Consented patients with imaging data.

Measure the relationship between lead bending stiffness and in vivo curvature \*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the intracardiac region will be determined during two or more cardiac cycles. The relationship between lead stiffness and curvature will be evaluated.

Outcome measures

Outcome measures
Measure	Consented Patients With RV Pacing Leads and Defibrillation Leads n=109 Participants Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane)
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Intracardiac Region Determined During Two or More Cardiac Cycles	109 Participants

PRIMARY outcome

Timeframe: Approximately 1 month

Population: Consented patients with imaging data.

Assess the relationship between subject and implant variables and lead curvature \*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the connector region were determined during specified arm movements. The relationship between lead stiffness and curvature was evaluated.

Outcome measures

Outcome measures
Measure	Consented Patients With RV Pacing Leads and Defibrillation Leads n=109 Participants Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane)
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements	109 Participants

Adverse Events

Consented Patients With RV Pacing Leads and Defibrillation Leads

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Piccini

Duke University Medical Center

Phone: 919-668-8049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place