Sinus Node DiseaseB3NCT02579889
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
A study testing DDD+CLS and DDD(R) in people with Sinus Node Disease, run by Biotronik SE & Co. KG at 54 sites in 9 countries.
Trial summary
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Disease
- What is being tested?
- DDD+CLS and DDD(R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,390 participants
- Where
- 54 sitesin 9 countries
- Study dates
- Sep 2015to Dec 2023
- 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
- Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines;
- Patients for whom dual-chamber pacing is indicated or preferred;
- Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment;
- Closed Loop Stimulation function was not previously activated;
- No stroke events from implant;
- Patient implanted for the first time;
Who cannot join
- Permanent AF (PermAF)
- NYHA Class IV Heart Failure
- Stage V kidney dysfunction
- Any indication to Cardiac Resynchronization Therapy (CRT)
- Life expectancy < 1
- Minors
Show all 9Show fewer
- Pregnant or breast-feeding patients
- Participation in another interventional trial
- Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery < 3 m
Trial locations and contacts
54 sites in 9 countries.
54 sites in 9 countries
Italy34 sites
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Bari, 70021
Azienda Ospedaliera Policlinico Consorziale
Bari
Ospedale Antonio Cardarelli
Campobasso, 86100
Ospedale F. Ferrari
Casarano, Lecce
Azienda Ospedaliera di Caserta Sant'Anna e San Sebastiano
Caserta
A.O.U. Policlinico Vittorio Emanuele
Catania
Ospedale di Conegliano
Conegliano, Treviso, 31015
Ospedale Maria SS Addolorata
Eboli, Salerno, 84025
Ospedale Santa Maria Nuova
Florence, 50122
Ospedale Fabrizio Spaziani
Frosinone
ASST Valle Olona - Ospedale Sant'Antonio Abate
Gallarate
ASST RHODENSE - Ospedale Guido Salvini
Garbagnate
Ospedale Ferdinando Veneziale
Isernia, 86170
Ospedale Vito Fazzi
Lecce, 73100
Nuovo Ospedale delle Apuane
Massa, 54100
Ospedale V. Monaldi
Naples, 80131
A.O.P. Federico II
Naples
A.O.U Maggiore della Carità di Novara
Novara, 28100
Ospedale Santa Maria della Stella
Orvieto, Terni, 05018
Azienda Ospedaliera di Padova
Padova
Ospedale S. Maria della Misericordia
Perugia
Nuovo Ospedale Santo Stefano
Prato, 59100
Ospedale "Maria Paternò Arezzo"
Ragusa, 97100
Ospedale di Rho
Rho, Italia, 20017
Ospedale Infermi di Rimini
Rimini, 47923
Policlinico Umberto I
Roma, 00161
Policlinico Casilino
Roma, 00169
Fondazione Policlinico Universitario Agostino Gemelli
Rome
Presidio Ospedaliero Ospedale Sant'Anna
San Fermo della Battaglia, Como, 22020
Ospedale Civile SS. Annunziata
Savigliano, Cuneo, 12038
Ospedale "Bolognini"
Seriate, Bergamo
Azienda Ospedaliera "S. Maria" di Terni
Terni, 05100
Ospedali Riuniti di Ancona
Torrette, Ancona, 60126
Ospedale di Treviso
Treviso, 31100
South Korea6 sites
Sejong General Hospital
Bucheon-si, 14154
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Seul National University Bundang Hospital
Gyeonggi-do
Korea University Anam Hospital
Seoul, 02841
Seul National University Hospital
Seoul, 03080
Pusan National University Yangsan Hospital
Yangsan
Taiwan4 sites
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan
Chang Gung Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
China3 sites
Xuanwu Hospital Capital Medical University
Beijing, West City District, 100053
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Nangang District
Wuhan Asia Heart Hospital
Wuhan, Jinghan District, 430022
Singapore2 sites
National Heart Center Singapore
Singapore, 169609
Tan Tock Seng Hospital
Singapore, 308433
Spain2 sites
Hospital General Universitario de Alicante
Alicante
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease - B3 Study
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.
Read the detailed description
The benefits of rate-responsiveness on top of dual-chamber pacing still need to be definitively assessed in Sinus Node Dysfunction (SND). Although many rate responsive (RR) sensors have been developed, no large clinical trials evaluated their benefits in terms of clinical endpoints such as clinically relevant atrial fibrillation (AF) and stroke. Electromechanical sensors (piezoelectric accelerometers) have been widely used for their simplicity and overall reliability. However there is some evidence indicating the Closed Loop Stimulation as one of the more efficient and physiological sensors.
Two randomized clinical studies have been conducted so far, showing that in the Brady-Tachy Syndrome the CLS algorithm was associated with a significantly lower overall atrial arrhythmia burden as compared both with a DDDR mode based on a standard accelerometric sensor and an atrial overdrive approach.
Both studies yielded consistent results, albeit with a parallel and intraindividual comparison designs, respectively. The atrial arrhythmic burden is an important but surrogate endpoint, not necessarily related to long-term clinical outcome. The CLS effects on AF (if any) should be investigated in terms of time to first new onset of clinically relevant AF.
In the light of these considerations, it appears interesting to run a large randomized study coherently collecting data on the overall clinical benefit of CLS, primarily in terms of AF and stroke, in a population indicated for pacemaker or ICD and needing dual-chamber pacing due to SND.
- Conditions
- Sinus Node Disease
- Being tested
- DDD+CLS, DDD(R)
- Keywords
- Closed Loop Stimulation, Atrial Fibrillation, Stroke, Heart Failure, Pacemaker, ICD
- Medical subject headings
- Sick Sinus Syndrome, Atrial Fibrillation, Stroke, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDD+CLSDevice
Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON
DDD(R)Device
Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF
| Study group | Role | What they receive |
|---|---|---|
| Active group - CLS ON | Experimental | Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON; Intervention: DDD+CLS Receives: Device: DDD+CLS |
| Control group - CLS OFF | Active comparator | Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF Receives: Device: DDD(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first.
Measured: three years
Secondary outcomes (6)
Sustained Paroxysmal AF (SPAF)
Assess the date of each events of SPAF occurred during the follow-up periods
Measured: Three years
Persistent AF
Assess the date of each events of peristent AF occurred during the follow-up periods
Measured: Three years
Permanent AF
Assess the date when AF is declared permanent
Measured: Three years
Stroke/TIA
Assess the date of each events of stroke/TIA occurred during the follow-up periods
Measured: Three years
Worsening Heart failure Hospitalization (wHF-H)
Assess the date of each events of wHF-H occurred during the follow-up periods
Measured: Three years
All cause mortality
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2023
- Study completionDec 2023
Why it stopped: Stopping criterion met (N. adjudicated EP1)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sinus Node DiseaseStudies of the same condition, open and under way.
- 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
- 1,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579889
- Sponsor's protocol ID
- BA104
- Acronym
- B3
- Status last verified
- Jan 2024
- First submitted
- 16 Oct 2015
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puglisi A, Altamura G, Capestro F, Castaldi B, Critelli G, Favale S, Pavia L, Pettinati G. Impact of Closed-Loop Stimulation, overdrive pacing, DDDR pacing mode on atrial tachyarrhythmia burden in Brady-Tachy Syndrome. A randomized study. Eur Heart J. 2003 Nov;24(21):1952-61. doi: 10.1016/j.ehj.2003.08.011.
PubMed 14585254Puglisi A, Favale S, Scipione P, Melissano D, Pavia L, Ascani F, Elia M, Scaccia A, Sagone A, Castaldi B, Musacchio E, Botto GL; Burden II Study Group. Overdrive versus conventional or closed-loop rate modulation pacing in the prevention of atrial tachyarrhythmias in Brady-Tachy syndrome: on behalf of the Burden II Study Group. Pacing Clin Electrophysiol. 2008 Nov;31(11):1443-55. doi: 10.1111/j.1540-8159.2008.01208.x.
PubMed 18950302Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
PubMed 22236222Russo V, Rago A, Papa AA, Golino P, Calabro R, Russo MG, Nigro G. The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study. Heart. 2013 Nov;99(21):1609-13. doi: 10.1136/heartjnl-2013-303878. Epub 2013 May 30.
PubMed 23723446de Cock CC, Giudici MC, Twisk JW. Comparison of the haemodynamic effects of right ventricular outflow-tract pacing with right ventricular apex pacing: a quantitative review. Europace. 2003 Jul;5(3):275-8. doi: 10.1016/s1099-5129(03)00031-x.
PubMed 12842643Lieberman R, Grenz D, Mond HG, Gammage MD. Selective site pacing: defining and reaching the selected site. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):883-6. doi: 10.1111/j.1540-8159.2004.00551.x.
PubMed 15189520Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
PubMed 12063369Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902.
PubMed 10805823Toff WD, Camm AJ, Skehan JD; United Kingdom Pacing and Cardiovascular Events Trial Investigators. Single-chamber versus dual-chamber pacing for high-grade atrioventricular block. N Engl J Med. 2005 Jul 14;353(2):145-55. doi: 10.1056/NEJMoa042283.
PubMed 16014884
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease - B3 Study
- ClinicalTrials.gov ID
- NCT02579889
- Acronym / sponsor ID
- B3 / BA104
- Conditions
- Sinus Node Disease
- Keywords
- Closed Loop Stimulation, Atrial Fibrillation, Stroke, Heart Failure, Pacemaker, ICD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopping criterion met (N. adjudicated EP1)
- Enrolment
- 1,390 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 20 Oct 2015 (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.
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.
Detailed description
The benefits of rate-responsiveness on top of dual-chamber pacing still need to be definitively assessed in Sinus Node Dysfunction (SND). Although many rate responsive (RR) sensors have been developed, no large clinical trials evaluated their benefits in terms of clinical endpoints such as clinically relevant atrial fibrillation (AF) and stroke. Electromechanical sensors (piezoelectric accelerometers) have been widely used for their simplicity and overall reliability. However there is some evidence indicating the Closed Loop Stimulation as one of the more efficient and physiological sensors.
Two randomized clinical studies have been conducted so far, showing that in the Brady-Tachy Syndrome the CLS algorithm was associated with a significantly lower overall atrial arrhythmia burden as compared both with a DDDR mode based on a standard accelerometric sensor and an atrial overdrive approach.
Both studies yielded consistent results, albeit with a parallel and intraindividual comparison designs, respectively. The atrial arrhythmic burden is an important but surrogate endpoint, not necessarily related to long-term clinical outcome. The CLS effects on AF (if any) should be investigated in terms of time to first new onset of clinically relevant AF.
In the light of these considerations, it appears interesting to run a large randomized study coherently collecting data on the overall clinical benefit of CLS, primarily in terms of AF and stroke, in a population indicated for pacemaker or ICD and needing dual-chamber pacing due to SND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group - CLS ON | Experimental | Device: DDD+CLSDevice will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON; Intervention: DDD+CLS |
| Control group - CLS OFF | Active comparator | Device: DDD(R)Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines;
- Patients for whom dual-chamber pacing is indicated or preferred;
- Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment;
- Closed Loop Stimulation function was not previously activated;
- No stroke events from implant;
Key exclusion criteria (9 listed)
- Permanent AF (PermAF)
- NYHA Class IV Heart Failure
- Stage V kidney dysfunction
- Any indication to Cardiac Resynchronization Therapy (CRT)
- Life expectancy < 1
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 |
|---|---|---|
| DDD+CLSDevice will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON | Device | Active group - CLS ON |
| DDD(R)Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF | Device | Control group - CLS OFF |
Primary outcome
First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first.
Time frame: three years
6 secondary outcomes
Sustained Paroxysmal AF (SPAF)
Time frame: Three years
Persistent AF
Time frame: Three years
Permanent AF
Time frame: Three years
Stroke/TIA
Time frame: Three years
Worsening Heart failure Hospitalization (wHF-H)
Time frame: Three years
All cause mortality
Time frame: Three years
Results and safety
The study was stopped early (reason given: Stopping criterion met (N. adjudicated EP1)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Results publication: PubMed 14585254Puglisi A, Altamura G, Capestro F, Castaldi B, Critelli G, Favale S, Pavia L, Pettinati G. Impact of Closed-Loop Stimulation, overdrive pacing, DDDR pacing mode on atrial tachyarrhythmia burden in Brady-Tachy Syndrome. A randomized study. Eur Heart J. 2003 Nov;24(21):1952-61. doi: 10.1016/j.ehj.2003.08.011.
- Results publication: PubMed 18950302Puglisi A, Favale S, Scipione P, Melissano D, Pavia L, Ascani F, Elia M, Scaccia A, Sagone A, Castaldi B, Musacchio E, Botto GL; Burden II Study Group. Overdrive versus conventional or closed-loop rate modulation pacing in the prevention of atrial tachyarrhythmias in Brady-Tachy syndrome: on behalf of the Burden II Study Group. Pacing Clin Electrophysiol. 2008 Nov;31(11):1443-55. doi: 10.1111/j.1540-8159.2008.01208.x.
- Results publication: PubMed 22236222Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
- Results publication: PubMed 23723446Russo V, Rago A, Papa AA, Golino P, Calabro R, Russo MG, Nigro G. The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study. Heart. 2013 Nov;99(21):1609-13. doi: 10.1136/heartjnl-2013-303878. Epub 2013 May 30.
- Results publication: PubMed 12842643de Cock CC, Giudici MC, Twisk JW. Comparison of the haemodynamic effects of right ventricular outflow-tract pacing with right ventricular apex pacing: a quantitative review. Europace. 2003 Jul;5(3):275-8. doi: 10.1016/s1099-5129(03)00031-x.
- Results publication: PubMed 15189520Lieberman R, Grenz D, Mond HG, Gammage MD. Selective site pacing: defining and reaching the selected site. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):883-6. doi: 10.1111/j.1540-8159.2004.00551.x.
- Results publication: PubMed 12063369Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
- Results publication: PubMed 10805823Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902.
- Results publication: PubMed 16014884Toff WD, Camm AJ, Skehan JD; United Kingdom Pacing and Cardiovascular Events Trial Investigators. Single-chamber versus dual-chamber pacing for high-grade atrioventricular block. N Engl J Med. 2005 Jul 14;353(2):145-55. doi: 10.1056/NEJMoa042283.
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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.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDD+CLS and DDD(R) in people with Sinus Node Disease, run by Biotronik SE & Co. KG at 54 sites in 9 countries.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Italy, South Korea, Taiwan, China, Singapore and 4 more countries. 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 was stopped early (reason given: Stopping criterion met (N. adjudicated EP1)). Results are not available in the source record.
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?
First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first. (time frame: three 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 NCT02579889, which also lists 9 linked publications.
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 18 Jan 2024.