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OpenTrials
Completed

NCT Number: NCT00419640

SAFE Study - 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital, The University Hospital of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.
  • Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  • Be at least 18 years old.

Exclusion criteria

  • Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
  • Are expected to have heart surgery within the next 6 months.
  • Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
  • Are expected not to be able to tolerate high rate pacing.
  • Have less than 12 months' life expectancy.
  • Are on the cardiac transplantation list.
  • Are in chronic AF.
  • Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).

Treatment and study plan

Pacemaker implantation with RA lead in LAS position

Device

Pacemaker implantation with RA lead placed in low atrial septal position

Other names: Identity ADx DR device

Pacemaker implantation with RA lead in RAA position

Device

Pacemaker implantation with RA lead placed in right atrial appendage position

Other names: Identity ADx DR pacemaker

Primary outcomes

  1. Persistent AF and chronic AF

    Time frame: 2 years

Secondary outcomes

  1. Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden

    Time frame: 2 years

  2. Number of cardioversions

    Time frame: 2 years

  3. Safety and efficacy of low septal pacing

    Time frame: 2 years

  4. Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo

    Time frame: 2 years

  5. Quality-of-life questionnaire: Short Form-36 (SF-36)

    Time frame: 2 years

  6. Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Septal Pacing for Atrial Fibrillation Suppression Evaluation

Acronym: SAFE

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2007
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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