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

November 20, 2007
July 10, 2013
December 2007
March 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00562107 on ClinicalTrials.gov Archive Site
Evolution of paroxysmal AV blocks [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evolution of paroxysmal AV blocks [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

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)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
    AAISafeR/SafeR ON
  • Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
    DDD(R) (SafeR OFF)
  • Experimental: 1
    AAIsafeR /SafeR Patient randomized with the SafeR switched ON
    Intervention: Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
  • Experimental: 2
    DDD(R) mode. Patients randomized with the SafeR mode switched OFF
    Intervention: Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
April 2013
March 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT00562107
ANSWER - IBSY02, IBSY02
Yes
Sorin Group
Sorin Group
Not Provided
Principal Investigator: Stockburger Martin, MD Head of Pacemaker/Defibrillator/CRT department
Sorin Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP