Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication (ANSWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562107
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : September 29, 2014
Information provided by (Responsible Party):

Brief Summary:

The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.

The expected benefits will be a result of the reduction of the percentage of ventricular pacing.

It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.

The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

Condition or disease Intervention/treatment Phase
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients. Device: Symphony DR 2550 and REPLY DR cardiac pacemakers Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
Study Start Date : December 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: 1
AAIsafeR /SafeR Patient randomized with the SafeR switched ON
Device: Symphony DR 2550 and REPLY DR cardiac pacemakers

Experimental: 2
DDD(R) mode. Patients randomized with the SafeR mode switched OFF
Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
DDD(R) (SafeR OFF)

Primary Outcome Measures :
  1. The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evolution of paroxysmal AV blocks [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
  • Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
  • Patient implanted with a bipolar right atrial lead and a right ventricular lead
  • Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

  • Patient with permanent AF
  • Patient suffering from sustained ventricular arrhythmias
  • Patient with congenital complete heart block
  • Patient with vasovagal syncope, carotid sinus syndrome
  • Patient with AV node ablation
  • Patient having suffered from a myocardial infarction within the last month
  • Patient suffering from severe aortic stenosis
  • Patient suffering from unstable angina pectoris
  • Patient is not able to understand the study objectives and protocol or refuses to co-operate
  • Patient is not available for scheduled follow-up
  • Patient has a life expectancy less than one year
  • Patient is included into another clinical study
  • Patient is minor, this is < 18 years
  • Patient is a pregnant woman
  • Any patient with a contra-indication for the device labeling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562107

United States, Massachusetts
736 Cambridge Street
Brighton, Massachusetts, United States, MA 02135
CHU - Hopital Sud
Amiens, France, 80054
Centre hospitalier de Béthune
Béthune, France, 62408
CHU - Hopital Michallon
Grenoble, France, 38043
CHP Beauregard
Marseille, France, 13012
CHU A de Villeneuve
Montpellier, France, 34295
Clinique Bizet
Paris cedex 16, France, 75116
CHU Hopital C. Nicolle
Rouen, France, 76035
Saint Denis, France, 93207
CHU - Hopital Nord
Saint Etienne, France, 42055
CHU Hautepierre
Strasbourg, France, 67098
Clinique Pasteur
Toulouse, France, 31076
CHU Hopital Trousseau
Tours, France, 37044
CHU de Nancy
Vandoeuvre les Nancy, France, 54511
Charite Virchow
Berlin, Germany
Bernau hospital
Bernau, Germany
Braunschweig hospital
Braunschweig, Germany, 38100
Elisabeth KH Essen
Essen, Germany, D-45138
Leipzig Uni
Leipzig, Germany, 04103
Lübeck Uni
Lübeck, Germany, D-23538
Lüdenscheid hospital
Lüdenscheid, Germany, 58515
Mainz Uni
Mainz, Germany, 55101
München Innenstadt
München, Germany, 80336
Remscheid hospital
Remscheid, Germany, 42859
Ulm Uni
Ulm, Germany, 89081
Clinica Villa Pini d'Abruzzo
Chieti, Italy, 66100
Osp Civile di Montebelluna
Conegliano, Italy, 31015
Ospedale Umberto I
Mestre, Italy, 30173
Presidio Ospedaliero di Mirano
Mirano, Italy, 30035
Azienda Ospedaliera S. Maria
Terni, Italy, 05100
Complejo Hospitalario Arquitecto Marcide
Ferrol, Spain, 15405
Hospital Universitario de Madrid
Madrid, Spain, 28041
Hospital Montecelo
Mourente, Spain, 36071
Salamanca, Spain
Hospital Clinico universitario de Santiago
Santiago de Compostela, Spain, 15706
Complejo Hospitalario Xeral-Cies
Vigo, Spain, 3204
United Kingdom
William Harvey Hospital
Ashford, United Kingdom, Kent TN24 OLZ
Sponsors and Collaborators
Principal Investigator: Stockburger Martin, MD Head of Pacemaker/Defibrillator/CRT department

Responsible Party: LivaNova Identifier: NCT00562107     History of Changes
Other Study ID Numbers: ANSWER - IBSY02
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014

Keywords provided by LivaNova:
Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF