Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease

Sinus Node Dysfunction Clinical Trial

Official title:

Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170611
• Other study ID #: PREFACE-IPRE03
• Secondary ID: IPRE03
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2010
• Last updated: July 26, 2010
• Start date: July 2004
• Est. completion date: January 2007

Study information

• Verified date: July 2010
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brady Tachy Syndrome
• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Device:
• PACEMAKER SYMPHONY 2550

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Monaco,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial arrhythmia burden			No