Clinical trial NCT01188356: EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
Official title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Arrhythmia
Keywords: Reply
Symphony
Atrial arrhythmias
V pacing
Evaluate the incidence and evolution over-time of co-morbidities
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 4350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.

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 (n=2188 patients) through a 2 years follow-up.

Detailed description: The study will focus on the number of patients moving to persistent Atrial Fibrillation as a function of cumulative %Vp (\< or \>40%), in a general dual-chamber pacemaker population through a 2 year follow-up (n=2188).

The same endpoint will be analyzed in sub populations (Sinus Node Disease and AVB) at 4 years follow up (n=4290).

Eligibility criteria: Inclusion Criteria:

- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.

Exclusion Criteria:

* Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
* Permanent or persistent atrial tachyarrhythmia

Primary outcomes:
measure: Atrial arrhythmias incidence
timeFrame: 2 years
measure: % ventricular pacing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Mesa
country: United States
facility: Mountain Vista Medical Center
state: Arizona
city: Mesa
country: United States
facility: Pacific Arrhythmia Services
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
facility: Advanced Heart and Vascular Institute
state: Arizona
city: Anaheim
country: United States
facility: Harishchandra N. Patel, M.D., Inc.
state: California
city: Anaheim
country: United States
facility: Narayan R. Devaraj, M.D., Inc.
state: California
city: Fremont
country: United States
facility: St. Rose Hospital
state: California
city: Hanford
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Simi Valley
country: United States
facility: Simi Valley Hospital
state: California
city: Newark
country: United States
facility: Metroform Medical Complex
state: Delaware
city: New Smyrna Beach
country: United States
facility: Complete Cardiology Care Live Oak Street
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital Cardiology
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia heart Center
state: Georgia
city: Warren
country: United States
facility: Electrophysiology Research Foundation
state: New Jersey
city: West Orange
country: United States
facility: Abbas Shehadeh, MD, PA
state: New Jersey
city: Beaufort
country: United States
facility: Low Country Medical Group
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
facility: East Ohio Rag Hospital
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Inc
state: Ohio
city: Carbondale
country: United States
facility: Lakshimi Mizin Cardiology
state: Pennsylvania
city: Clarks Green
country: United States
facility: Scranton Heart Institute
state: Pennsylvania
city: Easton
country: United States
facility: Easton Cardiology
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Cardiology
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
facility: Columbia Cardiology Consultants
state: South Carolina
city: Murrells Inlet
country: United States
facility: Ocean Cardiology
state: South Carolina
city: Pawleys Island
country: United States
state: South Carolina
city: Victoria
country: United States
facility: Victoria Heart and Vascular Center
state: Texas
city: Tugun
country: Australia
facility: John Flynn Private Hospital
state: Queensland
city: Arlon
country: Belgium
facility: Cliniques Sud Luxembourg
city: Baudour
country: Belgium
facility: RHMS Ath - Baudour
city: Brussels
country: Belgium
facility: Hôpital Brugmann
city: Izegem
country: Belgium
facility: vzw Sint-Jozefskliniek
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Namur
country: Belgium
facility: Clinique & Maternité Sainte-Elisabeth Namur
city: Verviers
country: Belgium
facility: Hôpital de La Tourelle
city: Montreal
country: Canada
facility: Hotel Dieu de Montreal
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont
city: Sherbrooke
country: Canada
facility: Chus-Fleurimont - Hospital
city: Trois-Rivieres
country: Canada
city: Bispebjerg
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Aix-en-Provence
country: France
facility: Polyclinique Parc Rambot
city: Albi
country: France
facility: CHG Albi
city: Annecy
country: France
facility: Centre hospitalier de la Région d'Annecy
city: Arras
country: France
facility: Cabinet médical
city: Brest
country: France
facility: Chu Brest
city: Brive La Gaillarde
country: France
facility: CH Brive
city: Cambrai
country: France
facility: Clinique Ste Marie
city: Chatellerault
country: France
facility: Clinique Bon Secours
city: Chaumont
country: France
facility: Ch Chaumont
city: Cherbourg
country: France
facility: Ch Cherbourg
city: Châlon-en-Champagne
country: France
facility: CH Châlon en Champagne
city: Clamart
country: France
facility: HIA Percy
city: Dinan
country: France
facility: CH René Pleven
city: Douarnenez
country: France
facility: CH Douarnenez
city: Evecquemont
country: France
facility: Centre Cardiologique d'Evecquemont
city: Evreux
country: France
facility: CH D'Evreux
city: Evry
country: France
facility: CMCO
city: Firminy
country: France
facility: CH de Firminy
city: Hagondange
country: France
city: Helfaut
country: France
facility: CH de la région St Omer
city: Henin Beaumont
country: France
facility: Cabinet de cardiologie
city: Lannion
country: France
facility: Cabinet de cardiologie
city: Lannion
country: France
facility: Centre Hospitalier Pierre Le Damany
city: Le Chesnay
country: France
facility: Cmc Parly Ii
city: Le Havre
country: France
facility: CH J. Monod
city: Lomme
country: France
facility: CH St Philibert
city: Lorient
country: France
facility: CH de Bretagne Sud
city: Lorient
country: France
facility: Ch de Bretagne Sud
city: Maubeuge
country: France
facility: Centre Hospitalier de Sambre Avesnois
city: Metz
country: France
facility: Hôpital Ste Blandine
city: Metz
country: France
facility: Clinique Claude Bernard
city: Montargis
country: France
facility: Clinique de Montargis
city: Montauban
country: France
facility: Clinique Pont de Chaume
city: Narbonne
country: France
facility: Cabinet de Cardiologie
city: Nogent Sur Marne
country: France
facility: Hopital Privé A. Brillard
city: Paris
country: France
facility: Hôpital Lariboisière
city: Poitiers
country: France
facility: CH Poitiers
city: Roanne
country: France
facility: Centre hospitalier général
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint Brieuc
country: France
facility: Centre hospitalier Yves Le Fol
city: Saint Denis
country: France
facility: CCN
city: Saint Etienne
country: France
facility: CHU - Hôpital Nord
city: Saint Malo
country: France
facility: CH Broussais
city: Saint Mande
country: France
facility: H.I.A. Begin
city: Soissons
country: France
facility: CH
city: St Nazaire
country: France
facility: CHG
city: Tulle
country: France
facility: Centre Hospitalier
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Valenciennes
country: France
facility: Ch Valenciennes
city: Vannes
country: France
facility: CH Vannes - CH Bretagne Atlantique
city: Alten
country: Germany
facility: Kardiologische Praxis Dr. Schröter
city: Annaberg-buchholz
country: Germany
facility: PRAXIS
city: Arnstadt
country: Germany
facility: Praxis Dr. Gerhard BÖHM
city: Aschersleben
country: Germany
facility: Dr. med. Kai-Uwe Westermann
city: Berlin
country: Germany
facility: FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung
city: Berlin
country: Germany
facility: Praxis Dr. Bott
city: Berlin
country: Germany
facility: Praxis Schmidt/Engelsing
city: Berlin
country: Germany
city: Bunde
country: Germany
facility: Innere Medizin und Kardiologie
city: Chemnitz
country: Germany
facility: Praxis Dr. Gloes
city: Chemnitz
country: Germany
facility: Praxis Dr. Med Stellmach
city: Chemnitz
country: Germany
facility: Praxis Troeger
city: Dresden
country: Germany
facility: Gesundheitszentrum Im Esc
city: Dusseldorf
country: Germany
facility: Praxis Engelhard Kaiser
city: Ebersbach
country: Germany
facility: Kardiologische Praxis
city: Eilenburg
country: Germany
facility: FA fur Innere Medizin/Kardiologie
city: Eilenburg
country: Germany
facility: Klinik Eilenburg
city: Eschwege
country: Germany
facility: Kardiologische Praxis
city: Frankfurt
country: Germany
facility: Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme
city: Frankfurt
country: Germany
facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
city: Grevesmuehlen
country: Germany
facility: DRK Krankenhaus Grevesmuehlen
city: Hanau
country: Germany
facility: Baerenfaenger Dr. Petra Private Practice
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt
city: Leipzig
country: Germany
facility: FA fur Innere Medizin/Kardiologie
city: Leipzig
country: Germany
facility: Praxis Dr. Andreas Herzfeld
city: Leipzig
country: Germany
facility: Praxis Dr. med. Irina Boran
city: Leipzig
country: Germany
facility: Praxis Schreiner
city: Lichtentanne
country: Germany
facility: Medizin/Kardiologie/Diabetologie
city: Lueneburg
country: Germany
facility: Staedt. Linikum Medizinische Klinik Lueneburg
city: Machern
country: Germany
facility: SPENGLER
city: Markkleeberg
country: Germany
facility: PRAXIS
city: Memmingen
country: Germany
city: Mühlhausen
country: Germany
facility: Kardiologische - angiologische Praxis Dr. med. Jörg Walter
city: München
country: Germany
facility: Klinikum Bogenhausen
city: Nordhausen
country: Germany
facility: Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel
city: Nordhausen
country: Germany
facility: Praxis für Gefäßmedizin
city: Oschatz
country: Germany
facility: Praxis Dr. Donaubauer
city: Papenburg
country: Germany
facility: Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke
city: Quedlinburg
country: Germany
facility: Med. Martina Trummel Praxis Innere Medizin / Kardiologie
city: Ratzeburg
country: Germany
facility: DRK Krankenhaus Ratzeburg
city: Schwarzenberg
country: Germany
facility: Praxis Dr. Noehring
city: Schwäbisch Hall
country: Germany
facility: Diakonie Klinikum Schwäbisch Hall GmbH
city: Starnberg
country: Germany
facility: Praxis Prof. Frey
city: Stollberg
country: Germany
facility: Praxis Dr. Birkenhagen
city: Weimar
country: Germany
facility: Sohien und Hufeland Klinikum Weimar Gmbh
city: Wunsiedel
country: Germany
facility: Praxis Dr Lebek
city: Zwickau
country: Germany
facility: Praxis Dr. Brode
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Conegliano
country: Italy
facility: Ospedale Civile di Conegliano
city: Firenze
country: Italy
facility: Arcispedale S. Maria Nuova
city: Firenze
country: Italy
facility: Ospedale Nuovo San Giovanni di Dio
city: Firenze
country: Italy
facility: Ospedale S. Maria Annunziata
city: Milano
country: Italy
facility: AOU S.Paolo
city: Montevarchi
country: Italy
facility: Ospedale Valdarno
city: Negrar
country: Italy
facility: Ospedale Sacrocuore - Don Calabria
city: Pisa
country: Italy
facility: University Hospital of Pisa
city: Salerno
country: Italy
facility: Ospedale OO.OO.San Giovanni e Ruggi d'Aragona
city: Hiroshima
country: Japan
facility: Shobara Red Cross Hospital
city: Kisarazu- city
country: Japan
facility: Kimitsu Chuo Hospital
city: Kyosai
country: Japan
facility: Yokosuka Kyosai General Hospital
city: Oita City
country: Japan
facility: National Hospital Organization Oita Medical Center
city: Osaka-shi
country: Japan
facility: Tominaga Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Osaka
country: Japan
facility: Osaka National Hospital
city: Suntou-gun
country: Japan
facility: Okamura Memorial Hospital
city: Tokyo
country: Japan
facility: Tokai University Tokyo Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
city: Toyokawa City
country: Japan
facility: Aoyama Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Denia
country: Spain
facility: Hospital Marina Salud de Denia
city: Elda
country: Spain
facility: Hospital general de Elda
city: Ferrol
country: Spain
facility: H.A. Marcide
city: Galdakao
country: Spain
facility: Hospital Galdakao
city: Gijon
country: Spain
facility: Cabuenes
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Lorca
country: Spain
facility: Hospital Rafael Mendez
city: Lugo
country: Spain
facility: Complejo Hospitalario Xeral Calde
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital de Fuenlabrada
city: Ourense
country: Spain
facility: CHOU
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Sevilla
country: Spain
facility: Virgen del Rocio
city: Tarragona
country: Spain
facility: Joan XXIII
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Xativa
country: Spain
facility: Hospital Lluis Alcanyis
city: Basel
country: Switzerland
city: Lausanne
country: Switzerland
city: Locarno
country: Switzerland
facility: Ospedale La Carità
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
Study officials:
References: