Clinical trial NCT01170611: Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
Official title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinus Node Dysfunction
Brady Tachy Syndrome
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

Detailed description: In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.

Eligibility criteria: Inclusion Criteria:

* A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
* A PR interval \<250ms AND
* Documented atrial arrhythmia in the past year
* Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
* Patients must have less than two known cardioversions within the last year
* Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

* Need a replacement pacemaker device
* Have an unknown PR interval
* Known AV block ≥ 250 ms PR interval
* Minor and/or pregnant woman
* Patients enrolled in other clinical trials
* Patients with sustained ventricular arrhythmia
* Patients with severe coronary artery disease (at the discretion of the investigator)
* Patients with advanced cardiomyopathy (at the discretion of the investigator)
* Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
* Patients with unstable angina pectoris
* Patients whose life expectancy is less than 1 year
* Patients who are unlikely to return for required follow-up visits
* Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
* Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
* Patient unable to understand the purpose of the study or refusing to cooperate

Primary outcomes:
measure: Atrial arrhythmia burden
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mesa
country: United States
facility: Banner Baywood Heart Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Brentwood Biomedical Research Institute
state: California
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Passaic
country: United States
facility: Passaic Beth Israel Regional Medical Center
state: New Jersey
city: Concord
country: United States
facility: NorthEast Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster Regional Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Aalst
country: Belgium
facility: OLV Aalst
city: Arlon
country: Belgium
facility: Cliniques Sud Luxembourg
city: Bruxelles
country: Belgium
facility: Clinique Saint-Jean
city: Geel
country: Belgium
facility: Algemeen Ziekenhuis Sint-Dimpna
city: Huy
country: Belgium
facility: Centre Hospitalier Hutois
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Wilrijk
country: Belgium
facility: Algemeen Ziekenhuis Sint-Augustinus
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne
city: Albi
country: France
facility: CHG d'Albi
city: Brest
country: France
facility: CHRU du Morvan Hôpital la Cavale Blanche
city: Clermond-Ferrand
country: France
facility: Hospice St-Jacques-Hôpital G.Montpied
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Foix
country: France
facility: C.H.I. du Val d'Ariège
city: Grenoble
country: France
facility: CHRU de Grenoble Hôpital Michallon
city: Lille
country: France
facility: Polyclinique du Bois
city: Limoges
country: France
facility: CHU de Limoges Hôpital Dupuytren
city: Marseille
country: France
facility: Clinique Clairval
city: Montpellier Cedex 5
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: InParys CLINIQUE BIZET
city: Pessac
country: France
facility: CHU Haut l'Evêque
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: CHU - Hôpital Charles Nicolle
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Centre Hospitalier Rangueil
city: Vandoeuvre Les Nancy
country: France
facility: CHU Brabois
city: Bad Langensalza
country: Germany
facility: Hufeland Krankenhaus GmbH
city: Berlin
country: Germany
facility: Charite Campus Virchow
city: Köln
country: Germany
facility: Kliniken der Stadt Köln
city: Leipzig
country: Germany
facility: Universitätklinikum Leipzig
city: Lübeck
country: Germany
facility: Universitätklinik. Lübeck
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität - Mainz Klinikum
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: Portogruaro
country: Italy
facility: Ospedale San Tommaso dei Battuti
state: VE
city: Monaco
country: Monaco
facility: CH Princesse Grace
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Vigo (CHUVI)
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: East Sussex
city: Chertsey
country: United Kingdom
facility: St Peters Hospital
state: Surrey
Study officials:
References: