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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of the Tendril 2088 lead in the LBBA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after the implantation |
| 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. | 6 months after the implantation |
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Inclusion Criteria:
Exclusion Criteria:
1. Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry
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Patients with an attempted LBBA implant with Abbott's Tendril 2088 lead
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| Name | Affiliation | Role |
|---|---|---|
| Kwangdeok Lee | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States | ||
| Eisenhower Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months after the implantation |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Developed Atrial Fibrillation with Atrial Lead | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Abbott | 9725269673 | kwangdeok.lee@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2024 | Jul 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2024 | Jul 8, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D012804 | Sick Sinus Syndrome |
| D006327 | Heart Block |
| D013575 | Syncope |
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Rancho Mirage |
| California |
| 92270 |
| United States |
| Cardiology Consultants - Baptist Campus | Pensacola | Florida | 32501 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2150 | United States |
| Hopital d'adulte de la Timone | Marseille | Alpes | 13005 | France |
| Medanta - The Medicity Hospital | Gurgaon | NCT DLH | 122001 | India |
| The Madras Medical Mission | Chennai | Tamil Nadu | 600037 | India |
| Ospedale S.Maria della Misericordia | Rovigo | Veneto | 45100 | Italy |
| National Heart Centre Singapore | Singapore | Singapore |
| Tan Tock Seng Hospital | Singapore | Singapore |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Left Ventricular Ejection Fraction | Left ventricular ejection fraction data were available only in 178 patients. | Mean | Standard Deviation | percentage |
|
|
|
| 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. | This analysis was performed on the successfully implanted population. | Posted | Count of Participants | Participants | 6 months after the implantation |
|
|
|
| 5 |
| 221 |
| 5 |
| 221 |
| 4 |
| 221 |
| Acute Decompensated Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Lead Dislodgement or Migration | Product Issues | Systematic Assessment |
|
| Mechanical Bump to Right Bundle Branch Resulting in Complete Heart Block | Cardiac disorders | Systematic Assessment |
|
| Bruising and Swelling at Insertion Site | General disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D000075224 | Cardiac Conduction System Disease |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |