Atrial FibrillationSAFENCT00419640
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
A study testing Pacemaker implantation with RA lead in LAS position and Pacemaker implantation with RA lead in RAA position in people with Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pacemaker implantation with RA lead in LAS position and Pacemaker implantation with RA lead in RAA position
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2005to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Queen Mary Hospital, The University Hospital of Hong Kong
Hong Kong
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Pacemaker implantation with RA lead in LAS position, Pacemaker implantation with RA lead in RAA position
- Keywords
- Sinus node disease, AV node disease
- Medical subject headings
- Atrial Fibrillation, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantation with RA lead in LAS positionDevice
Also called Identity ADx DR device
Pacemaker implantation with RA lead placed in low atrial septal position
Pacemaker implantation with RA lead in LAS positionDevice
Also called Identity ADx DR pacemaker
Pacemaker implantation with RA lead placed in low atrial septal position
Pacemaker implantation with RA lead in RAA positionDevice
Also called Identity ADx DR pacemaker
Pacemaker implantation with RA lead placed in right atrial appendage position
Pacemaker implantation with RA lead in RAA positionDevice
Also called Identity ADx DR pacemaker
Pacemaker implantation with RA lead placed in right atrial appendage position
| Study group | Role | What they receive |
|---|---|---|
| LAS + DAO ON | Experimental | The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Pacemaker implantation with RA lead in RAA position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent AF and chronic AF
Measured: 2 years
Secondary outcomes (6)
Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden
Measured: 2 years
Number of cardioversions
Measured: 2 years
Safety and efficacy of low septal pacing
Measured: 2 years
Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo
Measured: 2 years
Quality-of-life questionnaire: Short Form-36 (SF-36)
Measured: 2 years
Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startMay 2005
- Primary completionFeb 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chu-Pak Lau, Prof., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419640
- Sponsor's protocol ID
- CR04032AF
- Acronym
- SAFE
- Status last verified
- Feb 2019
- First submitted
- 8 Jan 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23868858
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septal Pacing for Atrial Fibrillation Suppression Evaluation
- ClinicalTrials.gov ID
- NCT00419640
- Acronym / sponsor ID
- SAFE / CR04032AF
- Conditions
- Atrial Fibrillation
- Keywords
- Sinus node disease, AV node disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LAS + DAO ON | Experimental | Device: Pacemaker implantation with RA lead in LAS positionThe right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON. |
| LAS + DAO OFF | Experimental | Device: Pacemaker implantation with RA lead in LAS positionThe right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF. |
| RAA + DAO ON | Experimental | Device: Pacemaker implantation with RA lead in RAA positionThe right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON. |
| RAA + DAO OFF | Active comparator | Device: Pacemaker implantation with RA lead in RAA positionThe right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantation with RA lead in LAS positionAlso: Identity ADx DR devicePacemaker implantation with RA lead placed in low atrial septal position | Device | LAS + DAO ON |
| Pacemaker implantation with RA lead in LAS positionAlso: Identity ADx DR pacemakerPacemaker implantation with RA lead placed in low atrial septal position | Device | LAS + DAO OFF |
| Pacemaker implantation with RA lead in RAA positionAlso: Identity ADx DR pacemakerPacemaker implantation with RA lead placed in right atrial appendage position | Device | RAA + DAO ON |
| Pacemaker implantation with RA lead in RAA positionAlso: Identity ADx DR pacemakerPacemaker implantation with RA lead placed in right atrial appendage position | Device | RAA + DAO OFF |
Primary outcome
Persistent AF and chronic AF
Time frame: 2 years
6 secondary outcomes
Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden
Time frame: 2 years
Number of cardioversions
Time frame: 2 years
Safety and efficacy of low septal pacing
Time frame: 2 years
Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo
Time frame: 2 years
Quality-of-life questionnaire: Short Form-36 (SF-36)
Time frame: 2 years
Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 23868858Lau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chu-Pak Lau, Prof. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation with RA lead in LAS position and Pacemaker implantation with RA lead in RAA position in people with Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent AF and chronic AF (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.