Clinical trial NCT00419640: SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
Official title: Septal Pacing for Atrial Fibrillation Suppression Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Sinus node disease
AV node disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Persistent AF and chronic AF
timeFrame: 2 years
Secondary outcomes:
measure: Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden
timeFrame: 2 years
measure: Number of cardioversions
timeFrame: 2 years
measure: Safety and efficacy of low septal pacing
timeFrame: 2 years
measure: Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo
timeFrame: 2 years
measure: Quality-of-life questionnaire: Short Form-36 (SF-36)
timeFrame: 2 years
measure: Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University Hospital of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Chu-Pak Lau, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.