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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

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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

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, Learn About Clinical Studies.

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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

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Sponsors and Collaborators
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Principal Investigator: Stockburger Martin, MD Head of Pacemaker/Defibrillator/CRT department
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Responsible Party: LivaNova Identifier: NCT00562107    
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