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
Information provided by:
Sorin Group Identifier:
First received: August 24, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

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.

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
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.


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.


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)
  Contacts and Locations
Please refer to this study by its identifier: NCT01188356

Contact: Alberto Borri +39 0161487211

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
Ch Valenciennes Recruiting
Valenciennes, France, 59300
Contact: AGRAOU, MD    03-27-14-30-41      
Principal Investigator: AGRAOU, MD         
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         
University Hospital of Pisa Recruiting
Pisa, Italy, 56038
Contact: MARIA GRAZIA BONGIORNI, MD    +39 050 993252   
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 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:
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 processed this record on April 22, 2014