SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation (SAFE)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pacemaker implantation with RA lead in LAS position; Device: Pacemaker implantation with RA lead in RAA position

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University Hospital of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Identity ADx DR pacemaker
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 Names: 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 Names: 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 Names: Identity ADx DR pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Persistent AF and chronic AF	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden	2 years
Number of cardioversions	2 years
Safety and efficacy of low septal pacing	2 years
Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo	2 years
Quality-of-life questionnaire: Short Form-36 (SF-36)	2 years
Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality	2 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Chu-Pak Lau, Prof., The University of Hong Kong

Publications and helpful links

General Publications

• Lau CP, Tachapong N, Wang CC, Wang JF, Abe H, Kong CW, Liew R, Shin DG, Padeletti L, Kim YH, Omar R, Jirarojanakorn K, Kim YN, Chen MC, Sriratanasathavorn C, Munawar M, Kam R, Chen JY, Cho YK, Li YG, Wu SL, Bailleul C, Tse HF; Septal Pacing for Atrial Fibrillation Suppression Evaluation Study Group. Prospective randomized study to assess the efficacy of site and rate of atrial pacing on long-term progression of atrial fibrillation in sick sinus syndrome: Septal Pacing for Atrial Fibrillation Suppression Evaluation (SAFE) Study. Circulation. 2013 Aug 13;128(7):687-93. doi: 10.1161/CIRCULATIONAHA.113.001644. Epub 2013 Jul 18.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 8, 2007
• First Submitted That Met QC Criteria: January 8, 2007
• First Posted (Estimate): January 9, 2007

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Sinus node disease; AV node disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CR04032AF