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Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) & success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS
Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects:
avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV lead electronically repositioning | Other | Single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Repositioning | Device | Change of pacing vectors for CRT pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU) | The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations. | From implant until first follow up (occurred between 3 or 6 month after implant procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Düsseldorf | 40225 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | LV Lead Electronically Repositioning | Single arm study: Electronic Repositioning: Change of pacing vectors for cardiac resynchronization therapy pacing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LV Lead Electronically Repositioning | Single arm study Electronic Repositioning: Change of pacing vectors for Cardiac Resynchronization Therapy pacing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU) | The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations. | Posted | Number | participants | From implant until first follow up (occurred between 3 or 6 month after implant procedure) |
|
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 | LV Lead Electronically Repositioning | Electronic Repositioning: Change of pacing vectors for CRT pacing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Defibrillation Threshold | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Winter, MD | Department of Cardiology and Rhythmology, Augusta Hospital, Duesseldorf, Germany. | +49 (0) 2118 | 1173 | joachim.winter@uniklinik-duesseldorf.de |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Years |
|
| 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 |
|
|
|
| 10 |
| 292 |
| 40 |
| 292 |
| 32 |
| 292 |
| Multiple heart failure symptoms | Cardiac disorders | Non-systematic Assessment |
|
| Deep vein thrombosis (DVT) | Cardiac disorders | Non-systematic Assessment |
|
| Death (no details) | General disorders | Non-systematic Assessment |
|
| Coronary Sinus Dissection | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastrointestinal disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Inappropriate pulse generator Shock | Product Issues | Non-systematic Assessment |
|
| Increase of Pacing Threshold | Product Issues | Non-systematic Assessment |
|
| Ineffective Pulse Generator Shock | Product Issues | Non-systematic Assessment |
|
| Inguinal Hernia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Lead Dislodgment | Product Issues | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pocket hematoma | Product Issues | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Syncope - Non cardiovascular | General disorders | Non-systematic Assessment |
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| Thoracic discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lead Replacement - Unknown reason | Product Issues | Non-systematic Assessment |
|
| Intervention for Coronary Artery Disease | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Death - Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Death - Hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Death - Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Elevated Pacing threshold | Product Issues | Non-systematic Assessment |
|
| Extracardiac stimulation | Product Issues | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Multiple heart failure symptoms | Cardiac disorders | Non-systematic Assessment |
|
| Immunotheraphy | Immune system disorders | Non-systematic Assessment |
|
| Atrial Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bruising | General disorders | Non-systematic Assessment |
|
| Cholecystomy | Gastrointestinal disorders | Non-systematic Assessment |
|
| Coronary sinus dissection | Surgical and medical procedures | Non-systematic Assessment |
|
| Lead Dislodgment | Product Issues | Non-systematic Assessment |
|
| Pacing system infection | Product Issues | Non-systematic Assessment |
|
| Pocket Hematoma | Product Issues | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Pulse Generator system issue | Product Issues | Non-systematic Assessment |
|
| Lead - Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
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