AssEssment of CoMorbidities & Atrial ArRhythmiA Burden In DuaL-Chamber PaceD Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Sorin Group.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01188356
First received: August 24, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 24, 2010 | ||||
| Last Updated Date | August 24, 2010 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | AssEssment of CoMorbidities & Atrial ArRhythmiA Burden In DuaL-Chamber PaceD Patients | ||||
| Official Title ICMJE | AssEssment of CoMorbidities & Atrial ArRhythmiA Burden In DuaL-Chamber PaceD Patients | ||||
| Brief Summary | 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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| Detailed Description | 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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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation. |
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| Condition ICMJE | Atrial Arrhythmia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 2188 | ||||
| Estimated Completion Date | March 2012 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, France, Germany, Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01188356 | ||||
| Other Study ID Numbers ICMJE | RGST04-EMERALD Study, RGST04 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Maria Grazia BONGIORNI, Division of Cardiology University Hospital of Pisa Pisa - ITALY | ||||
| Study Sponsor ICMJE | Sorin Group | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Sorin Group | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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