View Clinical Trial (Medical Research Study)
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden In DuaL-Chamber PaceD Patients
| City: |
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Carbondale , Pa |
| State: |
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Pennsylvania |
| Zip Code: |
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18407 |
| Conditions: |
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Atrial Arrhythmia |
| Purpose: |
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The purpose of this study is to evaluate the incidence and evolution over-time of
co-morbidities in a general dual-chamber pacemaker population through a 2 years follow-up.
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| Study Summary: |
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The study will particularly focus on the number of patients moving to persistent Atrial
Fibrillation as a function of pacing mode, pacing sites, and cumulative %Ap & %Vp, in a
general dual-chamber pacemaker population through a 2 year follow-up.
Sub-analyses will be performed stratifying patients per medical history (etiology,
co-morbidities, medical therapy, reasons of implant, primo-implant/replacement.
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| Criteria: |
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Inclusion Criteria:
- Patient implanted (primo-implant, replacement, upgrade) with one of the devices
listed in § 2.2 from less than two months.
- Patient has signed the consent to data treatment (according to the laws and
regulations of the country in which the observation is performed)
Exclusion Criteria:
1. Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
2. Permanent or persistent atrial tachyarrhythmia
3. Already included in another interventional clinical study
4. Life expectancy less than 24 months
5. Not available for routine follow-up visits.
6. Inability to understand the purpose of the study or refusal to cooperate
7. Under guardianship
8. Age of less than 18 years
9. Pregnancy (Women of childbearing potential should have a negative pregnancy test
prior to enrollment)
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| NCT ID: |
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NCT01188356 |
| Primary Contact: |
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Alberto Borri
Phone: +39 0161487211
Email: alberto.borri.brunetto@sorin.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Carbondale , Pa, Pennsylvania 18407
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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