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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Pacemaker implantation with RA lead in LAS position

Pacemaker implantation with RA lead in RAA position

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Sinus node disease, AV node disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

Queen Mary Hospital, The University Hospital of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

LAS + DAO ON

LAS + DAO OFF

RAA + DAO ON

RAA + DAO OFF

Arm Description

The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.

The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.

The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.

The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.

Outcomes

Primary Outcome Measures

Persistent AF and chronic AF

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT00419640

First Posted

January 8, 2007

Last Updated

February 1, 2019

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00419640

Brief Title

SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

Acronym

SAFE

Official Title

Septal Pacing for Atrial Fibrillation Suppression Evaluation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Sinus node disease, AV node disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

385 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LAS + DAO ON

Arm Type

Experimental

Arm Description

The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.

Arm Title

LAS + DAO OFF

Arm Type

Experimental

Arm Description

The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.

Arm Title

RAA + DAO ON

Arm Type

Experimental

Arm Description

The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.

Arm Title

RAA + DAO OFF

Arm Type

Active Comparator

Arm Description

The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.

Intervention Type

Device

Intervention Name(s)

Pacemaker implantation with RA lead in LAS position

Other Intervention Name(s)

Identity ADx DR device

Intervention Description

Pacemaker implantation with RA lead placed in low atrial septal position

Intervention Type

Device

Intervention Name(s)

Pacemaker implantation with RA lead in LAS position

Other Intervention Name(s)

Identity ADx DR pacemaker

Intervention Description

Pacemaker implantation with RA lead placed in low atrial septal position

Intervention Type

Device

Intervention Name(s)

Pacemaker implantation with RA lead in RAA position

Other Intervention Name(s)

Identity ADx DR pacemaker

Intervention Description

Pacemaker implantation with RA lead placed in right atrial appendage position

Intervention Type

Device

Intervention Name(s)

Pacemaker implantation with RA lead in RAA position

Other Intervention Name(s)

Identity ADx DR pacemaker

Intervention Description

Pacemaker implantation with RA lead placed in right atrial appendage position

Primary Outcome Measure Information:

Title

Persistent AF and chronic AF

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

Number of cardioversions

Time Frame

2 years

Title

Safety and efficacy of low septal pacing

Time Frame

2 years

Title

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

Time Frame

2 years

Title

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

Time Frame

2 years

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chu-Pak Lau, Prof.

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital, The University Hospital of Hong Kong

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Citations:

PubMed Identifier

23868858

Citation

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.

Results Reference

derived

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SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

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