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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT00562107
First received: November 20, 2007
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of paroxysmal AV blocks [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: December 2007
Study Completion Date: April 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AAIsafeR /SafeR Patient randomized with the SafeR switched ON
Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
AAISafeR/SafeR ON
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562107

Locations
United States, Massachusetts
736 Cambridge Street
Brighton, Massachusetts, United States, MA 02135
France
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
CCN
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
Germany
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
Italy
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
Spain
Complejo Hospitalario Arquitecto Marcide
Ferrol, Spain, 15405
Hospital Universitario de Madrid
Madrid, Spain, 28041
Hospital Montecelo
Mourente, Spain, 36071
Povisa
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
Sorin Group
Investigators
Principal Investigator: Stockburger Martin, MD Head of Pacemaker/Defibrillator/CRT department
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT00562107     History of Changes
Other Study ID Numbers: ANSWER - IBSY02, IBSY02
Study First Received: November 20, 2007
Last Updated: July 10, 2013
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ethics Committee
Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 18, 2014