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

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)

Study Overview

• Status: Completed
• Conditions: Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
• Intervention / Treatment: Device: Symphony DR 2550 and REPLY DR cardiac pacemakers; Device: Symphony DR 2550 and REPLY DR cardiac pacemakers

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; AAIsafeR /SafeR Patient randomized with the SafeR switched ON	Device: Symphony DR 2550 and REPLY DR cardiac pacemakers; AAISafeR/SafeR ON; Device: Symphony DR 2550 and REPLY DR cardiac pacemakers; DDD(R) (SafeR OFF)
Experimental: 2; DDD(R) mode. Patients randomized with the SafeR mode switched OFF	Device: Symphony DR 2550 and REPLY DR cardiac pacemakers; AAISafeR/SafeR ON; Device: Symphony DR 2550 and REPLY DR cardiac pacemakers; DDD(R) (SafeR OFF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Evolution of paroxysmal AV blocks	3 years

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Stockburger Martin, MD, Head of Pacemaker/Defibrillator/CRT department

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 20, 2007
• First Submitted That Met QC Criteria: November 20, 2007
• First Posted (Estimate): November 21, 2007

Study Record Updates

• Last Update Posted (Estimate): September 29, 2014
• Last Update Submitted That Met QC Criteria: September 26, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF
• Other Study ID Numbers: ANSWER - IBSY02; IBSY02