Trial Outcomes & Findings for LBBAP Data Collection Registry (NCT NCT05887323)
NCT ID: NCT05887323
Last Updated: 2024-10-08
Results Overview
The primary safety endpoint evaluates a LBBAP lead related SADE rate which is an appropriate measure for safety and consistent with the primary safety endpoints used for evaluating performance of the transvenous right ventricular lead.
Recruitment status
COMPLETED
Target enrollment
221 participants
Primary outcome timeframe
6 months after the implantation
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Left Bundle Branch Area Implant
Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).
Implantation of the Tendril 2088 lead in the LBBA: Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.
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|---|---|
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Overall Study
STARTED
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221
|
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Overall Study
Implant Attempt
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221
|
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Overall Study
6-Month
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221
|
|
Overall Study
COMPLETED
|
221
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Left Bundle Branch Area Implant
n=221 Participants
Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).
Implantation of the Tendril 2088 lead in the LBBA: Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.
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|---|---|
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Age, Categorical
<=18 years
|
1 Participants
n=221 Participants
|
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Age, Categorical
Between 18 and 65 years
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34 Participants
n=221 Participants
|
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Age, Categorical
>=65 years
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186 Participants
n=221 Participants
|
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Sex: Female, Male
Female
|
98 Participants
n=221 Participants
|
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Sex: Female, Male
Male
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123 Participants
n=221 Participants
|
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Region of Enrollment
Singapore
|
80 participants
n=221 Participants
|
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Region of Enrollment
United States
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78 participants
n=221 Participants
|
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Region of Enrollment
Italy
|
5 participants
n=221 Participants
|
|
Region of Enrollment
France
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25 participants
n=221 Participants
|
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Region of Enrollment
India
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33 participants
n=221 Participants
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Left Ventricular Ejection Fraction
|
53.3 percentage
STANDARD_DEVIATION 12.2 • n=178 Participants • Left ventricular ejection fraction data were available only in 178 patients.
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PRIMARY outcome
Timeframe: 6 months after the implantationThe primary safety endpoint evaluates a LBBAP lead related SADE rate which is an appropriate measure for safety and consistent with the primary safety endpoints used for evaluating performance of the transvenous right ventricular lead.
Outcome measures
| Measure |
Left Bundle Branch Area Implant
n=221 Participants
Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).
Implantation of the Tendril 2088 lead in the LBBA: Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.
|
|---|---|
|
The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).
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220 Participants
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PRIMARY outcome
Timeframe: 6 months after the implantationPopulation: This analysis was performed on the successfully implanted population.
The primary effectiveness endpoint evaluates the ability to pace and sense when the TendrilTM STS 2088 lead is implanted in the LBBA. This analysis was performed on the successfully implanted population.
Outcome measures
| Measure |
Left Bundle Branch Area Implant
n=201 Participants
Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).
Implantation of the Tendril 2088 lead in the LBBA: Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.
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|---|---|
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The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP
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187 Participants
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Adverse Events
Left Bundle Branch Area Implant
Serious events: 5 serious events
Other events: 4 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Left Bundle Branch Area Implant
n=221 participants at risk
Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).
Implantation of the Tendril 2088 lead in the LBBA: Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.
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|---|---|
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Cardiac disorders
Heart Failure
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1.4%
3/221 • 6 months
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Cardiac disorders
Acute Decompensated Heart Failure
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0.45%
1/221 • 6 months
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Product Issues
Lead Dislodgement or Migration
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0.45%
1/221 • 6 months
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Other adverse events
| Measure |
Left Bundle Branch Area Implant
n=221 participants at risk
Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).
Implantation of the Tendril 2088 lead in the LBBA: Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.
|
|---|---|
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Cardiac disorders
Developed Atrial Fibrillation with Atrial Lead
|
0.45%
1/221 • 6 months
|
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Cardiac disorders
Mechanical Bump to Right Bundle Branch Resulting in Complete Heart Block
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0.45%
1/221 • 6 months
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General disorders
Bruising and Swelling at Insertion Site
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0.45%
1/221 • 6 months
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Vascular disorders
Hematoma
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0.45%
1/221 • 6 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators are permitted to publish study-related results according to the local study contract and protocol. Draft publications or presentations must be provided to the Sponsor prior to any submission to determine if any confidential information is disclosed. Upon Sponsor request, the public disclosure may be delayed to enable the Sponsor to secure proprietary protection. The Sponsor shall not exercise editorial control over the proposed publication other than to correct technical accuracy.
- Publication restrictions are in place
Restriction type: OTHER