Bradycardia, Cardiomyopathies, Heart Block, Heart Failure, Sinus Node Dysfunction, Syncope
Conditions
Brief summary
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
Detailed description
This registry is a retrospective, observational, non-controlled chart review conducted to support an indication expansion of the Tendril STS 2088 lead to include pacing/sensing in the left bundle branch area. Data from a minimum of 220 attempted subjects will be included in order to have 190 evaluable subjects in this registry. The chart review will be conducted at up to 20 participating centers worldwide.
Interventions
DEVICEImplantation 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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in the Left Bundle Branch Area on or before January 31, 2023 and subject's medical records contain data through at least 6 months (+/- 3 months) after LBBAP implant attempt 2. Subject is ≥ 18 years of age or the legal age, whichever age is greater 3. For sites where the governing IRB/EC has not granted a waiver of informed consent, subject has either been informed of the nature of the clinical investigation using a privacy notice or has provided a signed written informed consent, as approved by the IRB/EC (Note: This inclusion criterion is not applicable for sites where the governing IRB/EC or applicable regulation has granted a waiver of patient consent)
Exclusion criteria
1\. Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs). | 6 months after the implantation | 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. |
| The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP | 6 months after the implantation | 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. |
Countries
France, India, Italy, Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 221 |
| Total | 221 |
Baseline characteristics
| Characteristic | Left Bundle Branch Area Implant | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 186 Participants | — |
| Age, Categorical Between 18 and 65 years | 34 Participants | — |
| Left Ventricular Ejection Fraction | 53.3 percentage STANDARD_DEVIATION 12.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 25 participants | — |
| Region of Enrollment India | 33 participants | — |
| Region of Enrollment Italy | 5 participants | — |
| Region of Enrollment Singapore | 80 participants | — |
| Region of Enrollment United States | 78 participants | — |
| Sex: Female, Male Female | 98 Participants | — |
| Sex: Female, Male Male | 123 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 221 |
| other Total, other adverse events | 4 / 221 |
| serious Total, serious adverse events | 5 / 221 |
Outcome results
Primary
The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP
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.
Time frame: 6 months after the implantation
Population: This analysis was performed on the successfully implanted population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Left Bundle Branch Area Implant | The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP | 187 Participants |
Primary
The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).
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.
Time frame: 6 months after the implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Left Bundle Branch Area Implant | The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs). | 220 Participants |