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The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
The purpose of this observational study is to collect data regarding the population of patients whit a Zephyrâ„¢ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients in Whom ACapâ„¢ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients in Whom ACapâ„¢ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients whit a Zephyrâ„¢ pacemaker implanted, models 5826 and 5820.
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| Name | Affiliation | Role |
|---|---|---|
| José Olagüe de Ros, PhD. | Hospital Universitario La Fe | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zephyr Pacemaker | Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zephyr Pacemaker | Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical |
| 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 | Percentage of Patients in Whom ACapâ„¢ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. | Posted | Number | percentage of patients | 12 months |
|
|
12 months
Serious Adverse Events were collected
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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 | Zephyr Pacemaker | Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant of a Percutaneous transluminal coronary angioplasty (PTCA) | Cardiac disorders | Non-systematic Assessment | On November 2009 patient was admitted into the hospital due to chest pain. Treated by Percutaneous transluminal coronary angioplasty (PTCA) On March 2010 two stents in middle descendent artery were implanted. We were aware on the 12 month follow-up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. José Olagüe | Hospital Universitari i politecnic La Fe | +34 961 24 40 00 | jolague@terra.com |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Percentage of Patients in Whom ACapâ„¢ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months). | Posted | Number | percentage of patients | 12 months |
|
|
|
| 18 |
| 70 |
| 0 |
| 70 |
|
| Hemorrhoids surgery | Gastrointestinal disorders | Non-systematic Assessment | Hemorrhoids surgery. The patient is discharged from hospital the same day (03/12/2009). |
|
| Bipolar disorder | Psychiatric disorders | Non-systematic Assessment | Patient was admitted due to a worsening of bipolar disorder during the hospitalization. The device was implanted on the 7th May 2009. Patient was discharged on the 12th May 2009. |
|
| Seizure crisis | Psychiatric disorders | Non-systematic Assessment | Patient was hospitalized due to seizure crisis from 21st to 28th October 2009. |
|
| Seizure crisis | Psychiatric disorders | Non-systematic Assessment | Patient was admitted into the hospital on the 13-Apr-2009 due to seizure crisis, during the hospitalization the device was implanted on the 07-may-2009. Patient discharged on the 29-may-2009. |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | Exitus - Death due to sudden death 05-jul-2009 (Myocardial infarction) |
|
| Pyramidal Syndrome | Nervous system disorders | Non-systematic Assessment | Patient was admitted in neurology service due to pyramidal syndrome. |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment | Patient was admitted in emergency service of another hospital on 16-jul-2009 due to palpitations. |
|
| Stent | Cardiac disorders | Non-systematic Assessment | Patient is implanted with stent. |
|
| Thoracic pain | Cardiac disorders | Non-systematic Assessment | Hospitalization prolonged due to thoracic pain treated with Nitroglycerin. |
|
| Transtympanic drain | Ear and labyrinth disorders | Non-systematic Assessment | Transtympanic drain |
|
| Decrease in immunological system | Immune system disorders | Non-systematic Assessment | Patient was hospitalized due to a decrease in immunological system. |
|
| Tracheotomy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient was admitted in emergency service and he was made a tracheotomy. |
|
| Hernioplasty | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient was admitted in surgery service to be made a hernioplasty. |
|
| Cerebral Hemorrhage | Vascular disorders | Non-systematic Assessment | Patient suffered a cerebral hemorrhage which caused the patient exitus. |
|
| Death | Cardiac disorders | Non-systematic Assessment | Patient did not present at follow-up so state of event was searched. Unknown cause. |
|
| Cholangitis | Hepatobiliary disorders | Non-systematic Assessment | Patient is committed in emergency service on 23-oct-2009 due to acute cholangitis and is discharged on 05-nov-2009. Cholecystectomy performed. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient is admitted at emergency service due to dyspnea. |
|
| Prostatectomy | Reproductive system and breast disorders | Non-systematic Assessment | Patient is admitted at hospital to proceed with prostatectomy. |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pneumothorax tension due to a secondary traumatic punction. |
|
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment | Patient is admitted in emergency service on 10-abr-2010 due to atrial flutter |
|
| Macroscopic Hematuria | Renal and urinary disorders | Non-systematic Assessment | Macroscopic hematuria due to antiaggregants treatment |
|
| Possible strange body in a wound. | Infections and infestations | Non-systematic Assessment | Patient was admitted in emergency service due to possible strange body in a wound. |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment | Patient is admitted in emergency service due to palpitations. Patient was discharged on the same day of admission. |
|
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| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |