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

Primary Purpose

Sinus Node Dysfunction, Brady Tachy Syndrome

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PACEMAKER SYMPHONY 2550
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sinus Node Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Banner Baywood Heart Hospital
  • Brentwood Biomedical Research Institute
  • Ochsner Clinic Foundation
  • University of Mississippi Medical Center
  • Passaic Beth Israel Regional Medical Center
  • NorthEast Medical Center
  • Hillcrest Medical Center
  • Lancaster Regional Medical Center
  • Drexel University College of Medicine
  • OLV Aalst
  • Cliniques Sud Luxembourg
  • Clinique Saint-Jean
  • Algemeen Ziekenhuis Sint-Dimpna
  • Centre Hospitalier Hutois
  • CHU Tivoli
  • Algemeen Ziekenhuis Sint-Augustinus
  • UCL Mont-Godinne
  • CHG d'Albi
  • CHRU du Morvan Hôpital la Cavale Blanche
  • Hospice St-Jacques-Hôpital G.Montpied
  • Hôpital Henri Mondor
  • C.H.I. du Val d'Ariège
  • CHRU de Grenoble Hôpital Michallon
  • Polyclinique du Bois
  • CHU de Limoges Hôpital Dupuytren
  • Clinique Clairval
  • Hôpital Arnaud de Villeneuve
  • Polyclinique de Gentilly
  • Nouvelles Cliniques Nantaises
  • Hôpital Pasteur
  • Hôpital Pitié-Salpêtrière
  • InParys CLINIQUE BIZET
  • CHU Haut l'Evêque
  • CHU Pontchaillou
  • CHU - Hôpital Charles Nicolle
  • Centre Cardiologique du Nord
  • Centre Hospitalier Rangueil
  • CHU Brabois
  • Hufeland Krankenhaus GmbH
  • Charite Campus Virchow
  • Kliniken der Stadt Köln
  • Universitätklinikum Leipzig
  • Universitätklinik. Lübeck
  • Klinikum Lüdenscheid
  • Johannes Gutenberg-Universität - Mainz Klinikum
  • Klinikum Memmingen
  • Ospedale San Tommaso dei Battuti
  • CH Princesse Grace
  • Complejo Hospitalario Universitario de Vigo (CHUVI)
  • Eastbourne District General Hospital
  • St Peters Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD

Arm Description

Outcomes

Primary Outcome Measures

Atrial arrhythmia burden

Secondary Outcome Measures

Full Information

First Posted
July 22, 2010
Last Updated
July 26, 2010
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT01170611
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LivaNova

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Dysfunction, Brady Tachy Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PACEMAKER SYMPHONY 2550
Primary Outcome Measure Information:
Title
Atrial arrhythmia burden

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Banner Baywood Heart Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Brentwood Biomedical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Passaic Beth Israel Regional Medical Center
City
Passaic
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
Facility Name
NorthEast Medical Center
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Lancaster Regional Medical Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
OLV Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Cliniques Sud Luxembourg
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Clinique Saint-Jean
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Dimpna
City
Geel
ZIP/Postal Code
2440
Country
Belgium
Facility Name
Centre Hospitalier Hutois
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
UCL Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
CHG d'Albi
City
Albi
ZIP/Postal Code
81013
Country
France
Facility Name
CHRU du Morvan Hôpital la Cavale Blanche
City
Brest
ZIP/Postal Code
29069
Country
France
Facility Name
Hospice St-Jacques-Hôpital G.Montpied
City
Clermond-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
C.H.I. du Val d'Ariège
City
Foix
ZIP/Postal Code
09017
Country
France
Facility Name
CHRU de Grenoble Hôpital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Polyclinique du Bois
City
Lille
ZIP/Postal Code
59003
Country
France
Facility Name
CHU de Limoges Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Clinique Clairval
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
ZIP/Postal Code
44277
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
6000
Country
France
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
InParys CLINIQUE BIZET
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
CHU Haut l'Evêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Centre Hospitalier Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Hufeland Krankenhaus GmbH
City
Bad Langensalza
ZIP/Postal Code
99947
Country
Germany
Facility Name
Charite Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Kliniken der Stadt Köln
City
Köln
ZIP/Postal Code
D-51067
Country
Germany
Facility Name
Universitätklinikum Leipzig
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
Facility Name
Universitätklinik. Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum Lüdenscheid
City
Lüdenscheid
ZIP/Postal Code
D-58515
Country
Germany
Facility Name
Johannes Gutenberg-Universität - Mainz Klinikum
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
Klinikum Memmingen
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Ospedale San Tommaso dei Battuti
City
Portogruaro
State/Province
VE
ZIP/Postal Code
30026
Country
Italy
Facility Name
CH Princesse Grace
City
Monaco
ZIP/Postal Code
98012
Country
Monaco
Facility Name
Complejo Hospitalario Universitario de Vigo (CHUVI)
City
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
East Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
St Peters Hospital
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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