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SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00419640
First received: January 8, 2007
Last updated: December 12, 2012
Last verified: December 2012
History of Changes

January 8, 2007
December 12, 2012
May 2005
February 2012   (final data collection date for primary outcome measure)
Persistent AF and chronic AF [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Free of persistent AF and chronic AF
Complete list of historical versions of study NCT00419640 on ClinicalTrials.gov Archive Site
  • Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of cardioversions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and efficacy of low septal pacing [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality-of-life questionnaire: Short Form-36 (SF-36) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Device diagnostic data: number of Atrial High Rate Episode, mode switch
  • episode and AF burden
  • Number of cardioversions
  • Safety and efficacy of low septal pacing
  • Echo parameters include left ventricular ejection fraction (LVEF) and diastolic
  • index using Doppler Echo
  • Quality-of-life questionnaire: SF-36
  • Major cardiovascular events: heart failure, stroke, hospitalization and
  • cardiovascular mortality
Not Provided
Not Provided
 
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
Septal Pacing for Atrial Fibrillation Suppression Evaluation

This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (AF) Suppression algorithm.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Atrial Fibrillation
  • Device: Pacemaker implantation with RA lead in LAS position
    Pacemaker implantation with RA lead placed in low atrial septal position
    Other Name: Identity ADx DR device
  • Device: Pacemaker implantation with RA lead in LAS position
    Pacemaker implantation with RA lead placed in low atrial septal position
    Other Name: Identity ADx DR pacemaker
  • Device: Pacemaker implantation with RA lead in RAA position
    Pacemaker implantation with RA lead placed in right atrial appendage position
    Other Name: Identity ADx DR pacemaker
  • Experimental: LAS + DAO ON
    The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.
    Intervention: Device: Pacemaker implantation with RA lead in LAS position
  • Experimental: LAS + DAO OFF
    The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.
    Intervention: Device: Pacemaker implantation with RA lead in LAS position
  • Experimental: RAA + DAO ON
    The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.
    Intervention: Device: Pacemaker implantation with RA lead in RAA position
  • Active Comparator: RAA + DAO OFF
    The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.
    Intervention: Device: Pacemaker implantation with RA lead in RAA position
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
385
November 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have a history of paroxysmal AF with documented AF episode within the last 6 months; documentation of AF is required. It can be documented by one of the following:

    • Holter documentation and the strip must be at least 30 seconds; OR
    • one page of 12-lead electrocardiogram (ECG); OR
    • transtelephonic recording for more than 15 seconds.
  2. Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.
  3. Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  4. Be at least 18 years old.

Exclusion Criteria:

  1. Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
  2. Are expected to have heart surgery within the next 6 months.
  3. Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
  4. Are expected not to be able to tolerate high rate pacing.
  5. Have less than 12 months' life expectancy.
  6. Are on the cardiac transplantation list.
  7. Are in chronic AF.
  8. Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00419640
CR04032AF
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Chu-Pak Lau, Prof. The University of Hong Kong
St. Jude Medical
December 2012

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