SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

Atrial Fibrillation Clinical Trial

— SAFE  

Official title:

Septal Pacing for Atrial Fibrillation Suppression Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419640
• Other study ID #: CR04032AF
• Status: Completed
• Phase: N/A
• Start date: May 2005
• Est. completion date: November 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: November 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
• Pacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
• Pacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position
• Pacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, The University Hospital of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Hong Kong, 

Outcome

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