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The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVIA Pacemaker | Device | patient has standard indication for pacemaker therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) | atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually. | 1 month follow-up completed |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Free Rate | Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients) | 1- and 3- month follow-up completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Ritter, Dr. | CHU Bordeaux Haut-Lévêque | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux Haut-Lévêque | Pessac | Bordeaux | F - 33604 | France |
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In this study the data of n = 175 patients from 34 clinical sites in Austria, Denmark, France, Germany, Spain, Sweden and United Kingdom are included. The period of investigation covered was between June 04, 2009 (day of first implant) and February 26, 2010 (day of last follow-up).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pacemaker Therapy | Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pacemaker Therapy | Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T) |
| 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 | Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) | atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually. | At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis). | Posted | Mean | 95% Confidence Interval | Volt | 1 month follow-up completed | (dual chamber pacemakers only at 1 mFU) | Participants |
|
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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 | Pacemaker Therapy | Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation / flutter related | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Others | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Evelyn Diessel | BIOTRONIK SE & Co.KG | +49 (0) 30 68905 | 1231 | evelyn.diessel@biotronik.com |
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| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| (dual chamber pacemakers only at 1 mFU) |
|
|
| Secondary | Complication Free Rate | Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients) | Posted | Number | 95% Confidence Interval | Percentage complication free patients | 1- and 3- month follow-up completed |
|
|
|
| 52 |
| 175 |
| 28 |
| 175 |
| ablation | Surgical and medical procedures |
|
| acute circulation insufficiency | Blood and lymphatic system disorders |
|
| bypass operation | Surgical and medical procedures |
|
| cardiac decompensation | Cardiac disorders |
|
| cardiogenic shock during implantation | Surgical and medical procedures |
|
| chest pain | Cardiac disorders |
|
| coronary angiography | Surgical and medical procedures |
|
| coronary artery disease related | Cardiac disorders |
|
| cystitis | Renal and urinary disorders |
|
| dementia | Nervous system disorders |
|
| diabetes related | Endocrine disorders |
|
| dialysis related | Renal and urinary disorders |
|
| fever and infection | Infections and infestations |
|
| foot amputation due to endocrine disorder | Surgical and medical procedures |
|
| hypotension | Cardiac disorders |
|
| intestinal disease | Gastrointestinal disorders |
|
| joint and bone related | Musculoskeletal and connective tissue disorders |
|
| lead dislocation | Surgical and medical procedures |
|
| lifestyle modification | Social circumstances |
|
| lung related hospitalisation | Respiratory, thoracic and mediastinal disorders |
|
| malnutrition | Metabolism and nutrition disorders |
|
| minor myocardial infarction | Cardiac disorders |
|
| noise hypersensibility | General disorders |
|
| non-cardiac death | Gastrointestinal disorders |
|
| non-cardiac death | Nervous system disorders |
|
| pacemaker/ICD exchange/repositioning | Surgical and medical procedures |
|
| pericardial effusion and pericardectomy | Surgical and medical procedures |
|
| pocket haematoma | Skin and subcutaneous tissue disorders |
|
| spinal disease | Nervous system disorders |
|
| stroke | Vascular disorders |
|
| circulation problems | Cardiac disorders |
|
| gastrointestinal disease | Gastrointestinal disorders |
|
| lead dislocation | Surgical and medical procedures |
|
| pacemaker related | Cardiac disorders |
|
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