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
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Purpose
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.
| Condition |
|---|
|
Atrial Arrhythmia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | AssEssment of CoMorbidities & Atrial ArRhythmiA Burden In DuaL-Chamber PaceD Patients |
Resource links provided by NLM:
Further study details as provided by Sorin Group:
Primary Outcome Measures:
- Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2188 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2012 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.
Criteria
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:
- Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
- Permanent or persistent atrial tachyarrhythmia
- Already included in another interventional clinical study
- Life expectancy less than 24 months
- Not available for routine follow-up visits.
- Inability to understand the purpose of the study or refusal to cooperate
- Under guardianship
- Age of less than 18 years
- Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188356
Contacts
| Contact: Alberto Borri | +39 0161487211 | alberto.borri.brunetto@sorin.com |
Locations
| United States, Florida | |
| Complete Cardiology Care Live Oak Street | Recruiting |
| New Smyrna Beach, Florida, United States | |
| Principal Investigator: LO, MD | |
| United States, Pennsylvania | |
| Lakshimi Mizin Cardiology | Recruiting |
| Carbondale , Pa, Pennsylvania, United States, 18407 | |
| Scranton Heart Institute | Recruiting |
| Clarks Green Pa, Pennsylvania, United States | |
| United States, South Carolina | |
| Coastal Cardiology | Recruiting |
| Charleston, South Carolina, United States | |
| Ocean Cardiology | Recruiting |
| Murrells Inlet, South Carolina, United States | |
| France | |
| Ch Valenciennes | Recruiting |
| Valenciennes, France, 59300 | |
| Contact: AGRAOU, MD 03-27-14-30-41 | |
| Principal Investigator: AGRAOU, MD | |
| Germany | |
| PRAXIS | Recruiting |
| Annaberg-buchholz, Germany, 9300 | |
| Contact: BERNHARDT, MD work 03733/66045 | |
| Principal Investigator: BERNHARDT, MD | |
| Praxis Schmidt / Engelsing | Recruiting |
| Berlin, Germany, 12159 | |
| Contact: ENGELSING MEIKE, MD 030/8519002 | |
| Principal Investigator: ENGELSING MEIKE, MD | |
| Gesundheitszentrum Im Esc | Recruiting |
| Dresden, Germany, 01277 | |
| Contact: HOHENSEE HARTMUT, MD 0351/4707245 | |
| Principal Investigator: HOHENSEE HARTMUT, MD | |
| Praxis Schreiner | Recruiting |
| Leipzig, Germany | |
| Contact: SCHREINER, MD 0341/9265550 | |
| Principal Investigator: SCHREINER, MD | |
| Principal Investigator: LOBE MATTHIAS, MD | |
| Medizin/Kardiologie/Diabetologie | Recruiting |
| Lichtentanne, Germany, 08115 | |
| Contact: FRANK STELZNER, MD (03 75) 7 92 89 18 | |
| Principal Investigator: FRANK STELZNER, MD | |
| SPENGLER | Recruiting |
| Machern, Germany, 04827 | |
| Contact: SPENGLER ULRIKE, MD 034292/73131 | |
| Principal Investigator: SPENGLER ULRIKE, MD | |
| PRAXIS | Recruiting |
| Markkleeberg, Germany, 04416 | |
| Contact: TAGGESELLE, MD 03413541651 | |
| Principal Investigator: TAGGESELLE, MD | |
| Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel | Recruiting |
| Nordhausen, Germany, 99734 | |
| Contact: HEINRICH, MD 03631 69488-0 | |
| Principal Investigator: HEINRICH, MD | |
| Med. Martina Trummel Praxis Innere Medizin / Kardiologie | Recruiting |
| Quedlinburg, Germany, 06484 | |
| Contact: TRUMMEL MARTINA, MD 03946 810877 | |
| Principal Investigator: TRUMMEL MARTINA, MD | |
| Praxis Prof. Frey | Recruiting |
| Starnberg, Germany, 82319 | |
| Contact: FREY, MD 08151 559055 | |
| Principal Investigator: FREY, MD | |
| Praxis Dr Lebek | Recruiting |
| Wunsiedel, Germany, 95632 | |
| Contact: LEBEK ROMAN, MD 09232 4006 | |
| Principal Investigator: LEBEK ROMAN, MD | |
| Italy | |
| University Hospital of Pisa | Recruiting |
| Pisa, Italy, 56038 | |
| Contact: MARIA GRAZIA BONGIORNI, MD +39 050 993252 m.g.bongiorni@med.unipi.it | |
| Principal Investigator: MARIA GRAZIA BONGIORNI, MD | |
Sponsors and Collaborators
Sorin Group
More Information
No publications provided
| Responsible Party: | Dr. Maria Grazia BONGIORNI, Division of Cardiology University Hospital of Pisa Pisa - ITALY |
| ClinicalTrials.gov Identifier: | NCT01188356 History of Changes |
| Other Study ID Numbers: | RGST04-EMERALD Study, RGST04 |
| Study First Received: | August 24, 2010 |
| Last Updated: | August 24, 2010 |
| Health Authority: | Italy: Ethics Committee Switzerland: Ethikkommission |
Keywords provided by Sorin Group:
|
Reply Symphony Atrial arrhythmias V pacing Evaluate the incidence and evolution over-time of co-morbidities |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Atrial Premature Complexes Heart Diseases |
Cardiovascular Diseases Pathologic Processes Cardiac Complexes, Premature |
ClinicalTrials.gov processed this record on May 22, 2013