Atrial FibrillationHECTO-AFNCT03197090
Handheld ECG Tracking of In-hOspital Atrial Fibrillation
A study testing Zenicor ECG in people with Atrial Fibrillation, run by Stéphane Cook, Prof at 1 site in Switzerland.
Trial summary
This is a single center, open label, randomized control trial to assess the efficacy of a one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial fibrillation (AF) in hospitalized patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Zenicor ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Mar 2018to 1 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the internal medicine department of the University and Hospital Fribourg throughout the study period will be screened for study enrollment.
Who cannot join
- Patients with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial
This is a single center, open label, randomized control trial to assess the efficacy of a one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial fibrillation (AF) in hospitalized patients.
All patients admitted to the internal medicine department of the Hospital Fribourg throughout the study period will be screened for study enrollment. Patients < 18 years, with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial. The study population will consist of approximately 800 patients in each group at the University of Fribourg Medical Center. Patients must meet all eligibility criteria for inclusion into the study.
Read more
Patients allocated to the treatment group will undergo twice daily monitoring with the handheld Zenicor ECG. Additional recordings will be obtained whenever patients notice palpitations. Recordings will be obtained in the presence of specially trained nurses. The recordings will then be validated through a web-based interface offered by Zenicor. The one-lead ECGs will be reviewed by the investigating physicians through the Web-based analysis service (Zenicor-ECG Doctor System) to assess the presence of atrial fibrillation.
The primary end point of the study is the percentage of newly detected atrial fibrillation at 6 months
- Conditions
- Atrial Fibrillation
- Being tested
- Zenicor ECG
- Keywords
- Screening, Zenicor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenicor ECGDevice
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.
| Study group | Role | What they receive |
|---|---|---|
| Zenicor ON | Experimental | Patients allocated to the experimental group will undergo systematic short ECG monitoring Receives: Device: Zenicor ECG |
| Zenicor OFF | No intervention | In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly detected in-hospital AF
Proportion of newly detected atrial fibrillation.
Measured: During hospitalizaion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start9 Mar 2018
- Primary completion31 Aug 2019
- Study completion1 Sep 2019
Why it stopped: poor patient recruitment and limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stéphane Cook, Prof
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stéphane Cook, Prof, University of Freiburg
- Investigators
- Stéphane P Cook, MD, Study chair, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197090
- Sponsor's protocol ID
- HECTO-AF Trial
- Acronym
- HECTO-AF
- Status last verified
- Apr 2020
- First submitted
- 10 Jun 2017
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
PubMed 25910800Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
PubMed 22922413Healey 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 22236222Mancinetti M, Schukraft S, Faucherre Y, Cook S, Arroyo D, Puricel S. Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial. Front Cardiovasc Med. 2021 May 4;8:681890. doi: 10.3389/fcvm.2021.681890. eCollection 2021.
PubMed 34017869Schukraft S, Mancinetti M, Hayoz D, Faucherre Y, Cook S, Arroyo D, Puricel S. Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol. Trials. 2019 Jan 30;20(1):92. doi: 10.1186/s13063-019-3189-7.
PubMed 30700332
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial
- ClinicalTrials.gov ID
- NCT03197090
- Acronym / sponsor ID
- HECTO-AF / HECTO-AF Trial
- Conditions
- Atrial Fibrillation
- Keywords
- Screening, Zenicor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor patient recruitment and limited resources
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Stéphane Cook, ProfUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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 single center, open label, randomized control trial to assess the efficacy of a one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial fibrillation (AF) in hospitalized patients.
All patients admitted to the internal medicine department of the Hospital Fribourg throughout the study period will be screened for study enrollment. Patients < 18 years, with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial. The study population will consist of approximately 800 patients in each group at the University of Fribourg Medical Center. Patients must meet all eligibility criteria for inclusion into the study.
Patients allocated to the treatment group will undergo twice daily monitoring with the handheld Zenicor ECG. Additional recordings will be obtained whenever patients notice palpitations. Recordings will be obtained in the presence of specially trained nurses. The recordings will then be validated through a web-based interface offered by Zenicor. The one-lead ECGs will be reviewed by the investigating physicians through the Web-based analysis service (Zenicor-ECG Doctor System) to assess the presence of atrial fibrillation.
The primary end point of the study is the percentage of newly detected atrial fibrillation at 6 months
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zenicor ON | Experimental | Device: Zenicor ECGPatients allocated to the experimental group will undergo systematic short ECG monitoring |
| Zenicor OFF | No intervention | –In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the internal medicine department of the University and Hospital Fribourg throughout the study period will be screened for study enrollment.
Key exclusion criteria (1 listed)
- Patients with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial.
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 |
|---|---|---|
| Zenicor ECGParticipants will place their thumbs on the device twice daily and whenever they notice palpitations. | Device | Zenicor ON |
Primary outcome
Newly detected in-hospital AF
Time frame: During hospitalizaion
Proportion of newly detected atrial fibrillation.
Results and safety
The study was stopped early (reason given: poor patient recruitment and limited resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 25910800Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
- Background: PubMed 22922413Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
- Background: 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.
- Derived from this study: PubMed 34017869Mancinetti M, Schukraft S, Faucherre Y, Cook S, Arroyo D, Puricel S. Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial. Front Cardiovasc Med. 2021 May 4;8:681890. doi: 10.3389/fcvm.2021.681890. eCollection 2021.
- Derived from this study: PubMed 30700332Schukraft S, Mancinetti M, Hayoz D, Faucherre Y, Cook S, Arroyo D, Puricel S. Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol. Trials. 2019 Jan 30;20(1):92. doi: 10.1186/s13063-019-3189-7.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Stéphane P Cook, MD study chair
University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenicor ECG in people with Atrial Fibrillation, run by Stéphane Cook, Prof at 1 site in Switzerland.
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 1 inclusion and 1 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 22 Oct 2021. 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 Switzerland. 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: poor patient recruitment and limited resources). 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?
Newly detected in-hospital AF (time frame: During hospitalizaion). 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 NCT03197090, which also lists 5 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 22 Oct 2021.