SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

NCT00419640 | Completed DMC

• 1 other identifier: CR04032AF
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Sinus node disease; AV node disease

Outcome Measures

Primary Outcomes (1)

• Persistent AF and chronic AF

  2 years

Secondary Outcomes (6)

• 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

Study Arms (4)

LAS + DAO ON

EXPERIMENTAL

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

LAS + DAO OFF

EXPERIMENTAL

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

RAA + DAO ON

EXPERIMENTAL

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

RAA + DAO OFF

ACTIVE COMPARATOR

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

Interventions

Pacemaker implantation with RA lead in LAS position DEVICE

Pacemaker implantation with RA lead placed in low atrial septal position

Also known as: Identity ADx DR device

LAS + DAO ON

Pacemaker implantation with RA lead in RAA position DEVICE

Pacemaker implantation with RA lead placed in right atrial appendage position

Also known as: Identity ADx DR pacemaker

RAA + DAO ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Queen Mary Hospital, The University Hospital of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 23868858 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Study Officials

• Chu-Pak Lau, Prof.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 9, 2007
• Study Start: May 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

HK (1)