Atrial FibrillationFAISCANCT04755010
"De Novo" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.
An observational study of Atrial Fibrillation and Heart Failure, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF. Both conditions share risk factors and the presence of the one worsens the progress of the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Linq II implantable cardiac monitor
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 1 Nov 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: On the basis of previously reported data, we estimated that the annual rate of AF in patients 65 years of age or older who have CHA2DS2VASc ≥ 2 and who have received an ICM or a pacemaker would be approximately 6%. We then estimated that with enrolment of 300 patients, the study would have 95% power to detect an episode of rapid atrial rate
Who may be able to join
- Patients with the previous diagnosis of HF with both preserved and depressed LVEF. Patients with preserved or intermediate LVEF will be defined according to current guidelines.
- Patients with signs and symptoms of HFor b) LVEF between 40 and 49 for "mid range" and greater than or equal to 50 for those with LVEF preserved, high natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)and at least one of these two criteria: Relevant structural disease (left ventricular hypertrophy or dilatation left earphone).
- Diastolic dysfunction.
Who cannot join
- Previous history of atrial fibrillation.
- CHA2DS2VASc < 2.
- Patients requiring ventricular pacing > 40 patients
- Patients under cardiac resynchronization therapy pacemaker/devices.
- Patients with severe valvulopathy.
- Patients with reverseble
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Moises Rodriguez Mañero
Santiago de Compostela, A Coruña, 15706
moises r rodriguez mañero, PhD, 616903275, moirmanero@gmail.com
Begoña Cardeso, begocardeso@gmail.com
About this study
Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF. Both conditions share risk factors and the presence of the one worsens the progress of the other. Therefore, the AF is not only relevant in terms of thromboembolic events. Timing of AF progression seems to be associated with an increase in all causes of mortality. Although, it is estimated that between 30%-40% of the patients with HF develop AF, given that in many cases it occurs with no apparent symptoms for the patients, is considered that the number of affected patients is greater. Since silent AF poses a problem of great impact in patients with HF, monitoring through continuous electrocardiographic registry could be useful in those patients with a higher risk of thromboembolic events. The purpose of this study is to understand the mechanism and biological and clinical relevance of the AF from a holistic approach. Trying to distinguish the symptomatic AF from the silent one using the implementation of insertable cardiac devices. The purpose of this study is 1. To determine in which percentage of patients with HF, episodes of AF both symptomatic and asymptomatic occur, as well as if the presence of AF represents an irrelevant fact in the progression of the insufficiency or in the contrary, it is the cause of the HF patients clinical decline. 2. To examine the presence of triggers of AF in patients with HF and to identify the presence of clinical markers, image markers of the atrium and left ventricle, as well as biomarkers which allow the risk of stratification and could mean future therapeutic targets.
Read the detailed description
Multicenter prospective study formed by units with experience in the management of patients with HF (Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Hospital Clínico Universitario de Salamanca, Salamanca, Spain and Hospital Universitario Virgen de la Arrixaca, Murcia, Spain).
Based on an AF development estimate of 30%, it has been estimated a minimum follow-up of 18 months and a maximum of 36 months for obtaining robust conclusions. On the basis of previously reported data, it has been estimated that the annual rate of AF in patients 65 years of age or older who have CHA2DS2VASc ≥ 2 and who have received an ICM is 6%. The enrolment of 300 patients had been estimated. The study would have 95% power to detect an episode of rapid atrial rate.
Those patients with a CHA2DS2VASc ≥2 seen in the HF unit will be prospectively included. In these patients, the previous diagnosis of AF will be assessed by means of clinical history and medical records. Patients with previous AF will be excluded.
Patients with preserved or intermediate LVEF will be defined according to current guidelines.
- Patients with signs and symptoms of HF.
- LVEF between 40 and 49 for "mid-range" and greater than or equal to 50 for those with LVEF preserved and at least one of these two criteria:
- High natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)
- Relevant structural disease (left ventricular hypertrophy or dilatation left earphone).
- Diastolic dysfunction.
The data will be collected individually by each recruiting center and introduced in the online registration form that will be enabled (see next point). The definition of variables will be agreed upon among all recruiting centers. The information collected will be dumped into a database created specifically for this purpose and will be coordinated from the Hospital Clínico de Santiago de Compostela.
Remote monitoring The CareLink remote monitoring system allows remote monitoring of patients, without the need to go to the hospital center. This system establishes a connection between the patient and the medical center, through the patient monitor that reads the information from the implanted device and transmits it to a secure server. This communication allows the transmission of clinically significant events or, in the case of wireless devices, the sending of alerts. In this way, the healthcare professional has information of the event and allows him to anticipate the evaluation and treatment with the consequent benefit for the patient.
Biological characterization
Human plasma samples: Total venous blood samples (10 ml) will be collected in EDTA tubes as anticoagulants and separated by centrifugation at 1500xg during 15 minutes plasma and cellular fractions. The supernatant and the cell pellet are transferred to tubes and stored at -80°C. The serological samples will be stored in each center of origin. Several determinations will be performed:
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Linq II implantable cardiac monitor
- Keywords
- Implantable cardiac monitoring
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linq II implantable cardiac monitorDevice
Implantation of Linq II implantable cardiac monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AF
Prevalence and predictor of atrial fibrillation in 300 patients with heart failure and without previous history of AF determined by the Reveal LINQ Insertable Cardiac Monitor
Measured: 3 years
Secondary outcomes (1)
Echocardiography
Number of patients with heart failure with low late left atrial strain rate and atrial fibrillation versus patients with normal left atrial strain determined by the Reveal LINQ Insertable Cardiac Monitor
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca, Hospital Universitario Virgen de la Arrixaca, Hospital Universitario San Juan de Alicante
- Responsible party
- Principal investigator, Moises Rodriguez Mañero, Hospital Clinico Universitario de Santiago
- Investigators
- moises rodriguez mañero, PhD, Principal investigator, Clínico Universitario de Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755010
- Sponsor's protocol ID
- 2019/082
- Acronym
- FAISCA
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The data will be collected individually by each recruiting center and introduced in the online registration form that will be enabled. Information collection will be dumped into a database created specifically for this purpose and will be coordinated from the Hospital Clínico de Santiago de Compostela.
Publications
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.
PubMed 24682347Healey JS, Alings M, Ha A, Leong-Sit P, Birnie DH, de Graaf JJ, Freericks M, Verma A, Wang J, Leong D, Dokainish H, Philippon F, Barake W, McIntyre WF, Simek K, Hill MD, Mehta SR, Carlson M, Smeele F, Pandey AS, Connolly SJ; ASSERT-II Investigators. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017 Oct 3;136(14):1276-1283. doi: 10.1161/CIRCULATIONAHA.117.028845. Epub 2017 Aug 4.
PubMed 28778946Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.
PubMed 28842973Piccini JP, Passman R, Turakhia M, Connolly AT, Nabutovsky Y, Varma N. Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace. 2019 Mar 1;21(3):404-413. doi: 10.1093/europace/euy222.
PubMed 30462208DeCicco AE, Finkel JB, Greenspon AJ, Frisch DR. Clinical significance of atrial fibrillation detected by cardiac implantable electronic devices. Heart Rhythm. 2014 Apr;11(4):719-24. doi: 10.1016/j.hrthm.2014.01.001. Epub 2014 Jan 3.
PubMed 24394157
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "De Novo" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.
- ClinicalTrials.gov ID
- NCT04755010
- Acronym / sponsor ID
- FAISCA / 2019/082
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- Implantable cardiac monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- University of Salamanca, Hospital Universitario Virgen de la Arrixaca, Hospital Universitario San Juan de Alicante
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 15 Feb 2021 (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.
Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF. Both conditions share risk factors and the presence of the one worsens the progress of the other. Therefore, the AF is not only relevant in terms of thromboembolic events. Timing of AF progression seems to be associated with an increase in all causes of mortality. Although, it is estimated that between 30%-40% of the patients with HF develop AF, given that in many cases it occurs with no apparent symptoms for the patients, is considered that the number of affected patients is greater. Since silent AF poses a problem of great impact in patients with HF, monitoring through continuous electrocardiographic registry could be useful in those patients with a higher risk of thromboembolic events. The purpose of this study is to understand the mechanism and biological and clinical relevance of the AF from a holistic approach. Trying to distinguish the symptomatic AF from the silent one using the implementation of insertable cardiac devices. The purpose of this study is 1. To determine in which percentage of patients with HF, episodes of AF both symptomatic and asymptomatic occur, as well as if the presence of AF represents an irrelevant fact in the progression of the insufficiency or in the contrary, it is the cause of the HF patients clinical decline. 2. To examine the presence of triggers of AF in patients with HF and to identify the presence of clinical markers, image markers of the atrium and left ventricle, as well as biomarkers which allow the risk of stratification and could mean future therapeutic targets.
Detailed description
Multicenter prospective study formed by units with experience in the management of patients with HF (Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Hospital Clínico Universitario de Salamanca, Salamanca, Spain and Hospital Universitario Virgen de la Arrixaca, Murcia, Spain).
Based on an AF development estimate of 30%, it has been estimated a minimum follow-up of 18 months and a maximum of 36 months for obtaining robust conclusions. On the basis of previously reported data, it has been estimated that the annual rate of AF in patients 65 years of age or older who have CHA2DS2VASc ≥ 2 and who have received an ICM is 6%. The enrolment of 300 patients had been estimated. The study would have 95% power to detect an episode of rapid atrial rate.
Those patients with a CHA2DS2VASc ≥2 seen in the HF unit will be prospectively included. In these patients, the previous diagnosis of AF will be assessed by means of clinical history and medical records. Patients with previous AF will be excluded.
Patients with preserved or intermediate LVEF will be defined according to current guidelines.
- Patients with signs and symptoms of HF.
- LVEF between 40 and 49 for "mid-range" and greater than or equal to 50 for those with LVEF preserved and at least one of these two criteria:
- High natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)
- Relevant structural disease (left ventricular hypertrophy or dilatation left earphone).
- Diastolic dysfunction.
The data will be collected individually by each recruiting center and introduced in the online registration form that will be enabled (see next point). The definition of variables will be agreed upon among all recruiting centers. The information collected will be dumped into a database created specifically for this purpose and will be coordinated from the Hospital Clínico de Santiago de Compostela.
Remote monitoring The CareLink remote monitoring system allows remote monitoring of patients, without the need to go to the hospital center. This system establishes a connection between the patient and the medical center, through the patient monitor that reads the information from the implanted device and transmits it to a secure server. This communication allows the transmission of clinically significant events or, in the case of wireless devices, the sending of alerts. In this way, the healthcare professional has information of the event and allows him to anticipate the evaluation and treatment with the consequent benefit for the patient.
Biological characterization
Human plasma samples: Total venous blood samples (10 ml) will be collected in EDTA tubes as anticoagulants and separated by centrifugation at 1500xg during 15 minutes plasma and cellular fractions. The supernatant and the cell pellet are transferred to tubes and stored at -80°C. The serological samples will be stored in each center of origin. Several determinations will be performed:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- On the basis of previously reported data, we estimated that the annual rate of AF in patients 65 years of age or older who have CHA2DS2VASc ≥ 2 and who have received an ICM or a pacemaker would be approximately 6%. We then estimated that with enrolment of 300 patients, the study would have 95% power to detect an episode of rapid atrial rate
Key inclusion criteria (3 listed)
- Patients with the previous diagnosis of HF with both preserved and depressed LVEF. Patients with preserved or intermediate LVEF will be defined according to current guidelines.
- Diastolic dysfunction.
Key exclusion criteria (6 listed)
- Previous history of atrial fibrillation.
- CHA2DS2VASc < 2.
- Patients requiring ventricular pacing > 40 patients
- Patients under cardiac resynchronization therapy pacemaker/devices.
- Patients with severe valvulopathy.
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 |
|---|---|---|
| Linq II implantable cardiac monitorImplantation of Linq II implantable cardiac monitor | Device | – |
Primary outcome
Incidence of AF
Time frame: 3 years
Prevalence and predictor of atrial fibrillation in 300 patients with heart failure and without previous history of AF determined by the Reveal LINQ Insertable Cardiac Monitor
1 secondary outcome
Echocardiography
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 24682347January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.
- Background: PubMed 28778946Healey JS, Alings M, Ha A, Leong-Sit P, Birnie DH, de Graaf JJ, Freericks M, Verma A, Wang J, Leong D, Dokainish H, Philippon F, Barake W, McIntyre WF, Simek K, Hill MD, Mehta SR, Carlson M, Smeele F, Pandey AS, Connolly SJ; ASSERT-II Investigators. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017 Oct 3;136(14):1276-1283. doi: 10.1161/CIRCULATIONAHA.117.028845. Epub 2017 Aug 4.
- Background: PubMed 28842973Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.
- Background: PubMed 30462208Piccini JP, Passman R, Turakhia M, Connolly AT, Nabutovsky Y, Varma N. Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace. 2019 Mar 1;21(3):404-413. doi: 10.1093/europace/euy222.
- Background: PubMed 24394157DeCicco AE, Finkel JB, Greenspon AJ, Frisch DR. Clinical significance of atrial fibrillation detected by cardiac implantable electronic devices. Heart Rhythm. 2014 Apr;11(4):719-24. doi: 10.1016/j.hrthm.2014.01.001. Epub 2014 Jan 3.
- Individual participant dataSharing planned: Undecided. The data will be collected individually by each recruiting center and introduced in the online registration form that will be enabled. Information collection will be dumped into a database created specifically for this purpose and will be coordinated from the Hospital Clínico de Santiago de Compostela.
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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.
moises rodriguez mañero, PhD principal investigator
Clínico Universitario de Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Heart Failure, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moises rodriguez mañero, PhD (616903275, moirmanero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AF (time frame: 3 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 NCT04755010, 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 15 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.