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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
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Device: Pacemaker implantation with RA lead in LAS position
Device: Pacemaker implantation with RA lead in RAA position

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Septal Pacing for Atrial Fibrillation Suppression Evaluation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Persistent AF and chronic AF [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 385
Study Start Date: May 2005
Study Completion Date: November 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS + DAO ON
The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.
 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
Experimental: LAS + DAO OFF
The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.
 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
Experimental: RAA + DAO ON
The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.
 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
Active Comparator: RAA + DAO OFF
The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419640

Locations
Hong Kong
Queen Mary Hospital, The University Hospital of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Chu-Pak Lau, Prof. The University of Hong Kong
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00419640     History of Changes
Other Study ID Numbers: CR04032AF
Study First Received: January 8, 2007
Last Updated: December 12, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by St. Jude Medical:
Sinus node disease
AV node disease

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013