Trial Outcomes & Findings for INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study (NCT NCT04346537)

Last Updated: 2022-07-14

Results Overview

This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %.

Recruitment status

COMPLETED

Target enrollment

109 participants

Primary outcome timeframe

Lead Implant through 3-Months Post-Implant

Results posted on

2022-07-14

Participant Flow

Unit of analysis: Leads

Participant milestones

Participant milestones
Measure	INGEVITY+ Study Participants Each participant was allowed to have up to 2 INGEVITY+ leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
Overall Study STARTED	109 201
Overall Study Implanted/Attempted With INGEVITY+ Lead	101 201
Overall Study COMPLETED	99 198
Overall Study NOT COMPLETED	10 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INGEVITY+ Study Participants n=109 Participants Enrolled INGEVITY+ Study Participants
Age, Continuous	73.2 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants
Brady Arrhythmia History Sinus Bradycardia	72 Participants n=5 Participants
Brady Arrhythmia History Sinus Node Dysfunction	29 Participants n=5 Participants
Brady Arrhythmia History Chronotropic Incompetence	7 Participants n=5 Participants
Brady Arrhythmia History Sinus Arrest	4 Participants n=5 Participants
Brady Arrhythmia History Atrioventricular Block - 1st Degree	4 Participants n=5 Participants
Brady Arrhythmia History Atrioventricular Block - 2nd Degree (Intermittent)	5 Participants n=5 Participants
Brady Arrhythmia History Atrioventricular Block - 2nd Degree (Permanent)	6 Participants n=5 Participants
Brady Arrhythmia History Atrioventricular Block - 3rd Degree (Intermittent)	2 Participants n=5 Participants
Brady Arrhythmia History Atrioventricular Block - 3rd Degree (Permanent)	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Lead Implant through 3-Months Post-Implant

Outcome measures

Outcome measures
Measure	INGEVITY+ Leads n=101 Participants Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who were implanted or attempted with INGEVITY+ lead(s). Of the 109 enrolled participants, there were 201 leads (101 implanted in right atrium, 99 implanted in right ventricle, 1 attempted in right ventricle) that met the eligibility criteria for inclusion in endpoint analyses.
Primary Safety: Lead-related Complication-Free Rate	98.5 Percentage of leads Interval 95.4 to Pre-specified analysis required lower one-sided confidence interval to be compared to performance goal of 93%. Upper confidence interval was irrelevant for endpoint analysis.

PRIMARY outcome

Timeframe: At 3-Months Post-Implant

Population: Of the 201 leads eligible for endpoint analysis, 15 did not contribute to data the analysis (1 had unsuccessful lead implant, 14 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data).

This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used.

Outcome measures

Outcome measures
Measure	INGEVITY+ Leads n=186 Leads Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who were implanted or attempted with INGEVITY+ lead(s). Of the 109 enrolled participants, there were 201 leads (101 implanted in right atrium, 99 implanted in right ventricle, 1 attempted in right ventricle) that met the eligibility criteria for inclusion in endpoint analyses.
Primary Efficacy: Pacing Capture Threshold Responder Rate	98.9 Percentage of leads Interval 96.2 to 99.9

SECONDARY outcome

Timeframe: At 3-Months Post-Implant

Population: Of the 101 right atrial leads eligible for endpoint analysis, 9 did not contribute to data the analysis due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data.

This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for atrial leads was \> 1.5 mV.

Outcome measures

Outcome measures
Measure	INGEVITY+ Leads n=92 Right Atrial Leads Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who were implanted or attempted with INGEVITY+ lead(s). Of the 109 enrolled participants, there were 201 leads (101 implanted in right atrium, 99 implanted in right ventricle, 1 attempted in right ventricle) that met the eligibility criteria for inclusion in endpoint analyses.
Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)	4.3 millivolts Interval 2.4 to 6.2

SECONDARY outcome

Timeframe: At 3-Months Post-Implant

Population: Of the 100 right ventricular leads eligible for endpoint analysis, 12 did not contribute to data the analysis (1 had unsuccessful lead implant, 11 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data).

This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for ventricular leads was \> 1.5 mV.

Outcome measures

Outcome measures
Measure	INGEVITY+ Leads n=88 Right Ventricular Leads Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who were implanted or attempted with INGEVITY+ lead(s). Of the 109 enrolled participants, there were 201 leads (101 implanted in right atrium, 99 implanted in right ventricle, 1 attempted in right ventricle) that met the eligibility criteria for inclusion in endpoint analyses.
Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)	15.9 millivolts Interval 10.5 to 24.0

SECONDARY outcome

Timeframe: At 3-Months Post-Implant

Population: Of the 201 leads eligible for endpoint analysis, 5 did not contribute to data the analysis (1 had unsuccessful lead implant, 4 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data).

This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were \> 300 ohms and \< 1300 ohms.

Outcome measures

Outcome measures
Measure	INGEVITY+ Leads n=196 Leads Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who were implanted or attempted with INGEVITY+ lead(s). Of the 109 enrolled participants, there were 201 leads (101 implanted in right atrium, 99 implanted in right ventricle, 1 attempted in right ventricle) that met the eligibility criteria for inclusion in endpoint analyses.
Secondary Efficacy: Pacing Impedance in Ohms	712 ohms Interval 696.0 to 729.0

Adverse Events

INGEVITY+ Study Participants

Serious events: 8 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	INGEVITY+ Study Participants n=101 participants at risk Each participant was allowed to have up to 2 INGEVITY+ leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
Product Issues Dislodgment - related to right atrial lead	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Product Issues Myocardial perforation post-implant - related right atrial lead	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Surgical and medical procedures Hemothorax	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Surgical and medical procedures Post-surgical infection (<=30 days post-implant)	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Cardiac disorders Atrial fibrillation	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Cardiac disorders Chest pain	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
General disorders Death	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Gastrointestinal disorders Diverticulitis	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Infections and infestations Systemic infection	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).

Other adverse events

Other adverse events
Measure	INGEVITY+ Study Participants n=101 participants at risk Each participant was allowed to have up to 2 INGEVITY+ leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
Product Issues Sensation of pacing with auto threshold - related to pulse generator	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Product Issues Dislodgment - related to right atrial lead	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Product Issues Dislodgment - related to right ventricular lead	0.99% 1/101 • Number of events 2 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Surgical and medical procedures Adverse reaction	2.0% 2/101 • Number of events 2 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Surgical and medical procedures Chest pain	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Cardiac disorders Atrial fibrillation	3.0% 3/101 • Number of events 3 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Cardiac disorders Atrial flutter	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Cardiac disorders Atrial tachycardia/Other supraventricular tachycardia	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
Cardiac disorders Deep vein thrombosis	0.99% 1/101 • Number of events 1 • Implant through 3-months post-implant. Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).

Additional Information

Gena Kantor

Boston Scientific

Phone: 1-800-227-3422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Restriction on the PI that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is equal to 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor reserves the right to require deletion of any Confidential Information or other proprietary information of Sponsor.
Publication restrictions are in place

Restriction type: OTHER