Atrial Fibrillation (AF)DEEP-AF-HFNCT07000942
Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms
A study testing Electrical cardioversion (ECV) in people with Atrial Fibrillation (AF) and Heart Failure (HF), run by M. Rienstra at 1 site in Netherlands.
Trial summary
Rationale: The co-existence of Atrial Fibrillation (AF) and Heart Failure (HF) is associated with increased morbidity, mortality, and hospital admissions, significantly contributing to healthcare burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure (HF), Electrical Cardioversion
- What is being tested?
- Electrical cardioversion (ECV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female patients with age ≥ 18 years
- Diagnosis of HF ≥90 days prior to screening NYHA class ≥ 2 on guideline-directed medical therapy.
- ECG-confirmed AF/Atrial flutter at screening
- Received oral anti-coagulants for ≥ 3 weeks (DOAC, vitamin K antagonists with an INR between 2 and 3) prior to screening
- Patients eligible for both treatment strategies judged by the investigator and physician.
- Provide written dated informed consent for participation prior to trial admission.
Who cannot join
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- Inability to understand and sign informed consent form
- Hospitalization for acute HF or worsening HF ≤ 3 months prior to screening
- Heart rate during AF/ atrial flutter ≥ 110 bpm, despite optimal rate control therapy at screening
- Paroxysmal or permanent AF/atrial flutter
- Previous left atrial ablation or surgery ≤ 3 months prior to screening
Show all 15Show fewer
- Planned catheter ablation at time of screening
- AF due to a reversible cause (e.g. post-operative AF, hyperthyroidism)
- Recent acute coronary syndrome, stroke/transient ischemic attack or cardiac intervention (≤90 days). Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical)
- Presence of (or scheduled for) mechanical assist device or heart transplantation
- Patients with complex congenital heart disease, up to the discretion of the investigator.
- Patients with current echocardiographic evidence of severe aortic-, mitral-, tricuspid- or pulmonary- valve disease (either stenosis or regurgitation)
- Patients with an intracardiac thrombus
- Expected life span from time of enrolment of ≤1 year, as assessed by the clinician
- Patient currently enrolled in another randomized clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
UMCG
Groningen, Provincie Groningen, 9713 GZ
Prof. Dr. M. Rienstra, +31(0)50 3612355, m.rienstra@umcg.nl
Prof. Dr. A.A. Voors, +31(0)50 3612355, a.a.voors@umcg.nl
About this study
Rationale:
The co-existence of Atrial Fibrillation (AF) and Heart Failure (HF) is associated with increased morbidity, mortality, and hospital admissions, significantly contributing to healthcare burden. Patients often experience overlapping symptoms, complicating identifying the disease primarily responsible for symptom burden. Electrical cardioversion (ECV) has been suggested to assess symptom status in sinus rhythm. However, the role of a diagnostic ECV in patients with AF and concomitant HF has not been established.
Read more
The hypothesis of this trial is that a diagnostic ECV can provide insight into AF-specific and HF-specific symptoms that can inform the physician and subsequently lead to treatment changes, as well as improve quality of life (QoL), and result changes in ejection fraction, cardiac output, and NT-proBNP levels.
Objective: To assess whether a diagnostic ECV results in more treatment changes after 3 months, compared to standard of care (no ECV).
Study design: This is an investigator initiated, randomized, open label with blinded endpoint evaluation, multi-centre, trial.
Study population: 112 patients with chronic HF and ECG confirmed persistent AF.
Trial intervention: Patients will be randomized in a 1:1 ratio to either an ECV or standard of care with pharmacological rate and/or rhythm control.
Main study parameters/endpoints:
The primary outcome: total number of treatment alterations by the physician during 3 months post intervention/randomization.
Secondary outcomes: Success rate of ECV, recurrences of AF at 4 weeks, QoL changes assessed by AFEQT and KCCQ score, echocardiographic changes (left ventricular ejection fraction (LVEF) and cardiac output (CO)), and laboratory changes (NT-proBNP) between baseline (pre-cardioversion) and 4 weeks (post-cardioversion). Whether the physician can distinguish AF from HF symptoms and whether ECV can be used as diagnostic tool.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a pragmatic trial, the study will be embedded within care according to current AF and HF guidelines, that includes ECV and rhythm and/or rate control, while acknowledging wide variability in local practises. The patients in the intervention arm will undergo a diagnostic ECV. Both groups will fill out questionnaires regarding QoL (baseline and 4 weeks) and have an echocardiogram at 4 weeks. A blinded endpoint committee will assess potential treatment alterations prescribed by the physician in both patient groups within 3 months. No harm is expected for this study as the intervention will be based on national guidelines.
- Being tested
- Electrical cardioversion (ECV)
- Keywords
- Electrical cardioversion, Quality of Life (QoL), Treatment changes
- 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.
Electrical cardioversion (ECV)Other
Electrical cardioversion in patients with persistent atrial fibrillation and chronic heart failure
| Study group | Role | What they receive |
|---|---|---|
| Electrical cardioversion (ECV) | Active comparator | Not described Receives: Other: Electrical cardioversion (ECV) |
| Standard of Care (SoC) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of treatment alterations
Total number of heart failure and/or atrial fibrillation treatment alterations by the physician
Measured: During 3 months post intervention/randomization
Secondary outcomes (9)
Success rate of the ECV
defined as ECG-confirmed sinus rhythm after ECV
Measured: At baseline
Changes in Quality of Life, as assessed by the Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) questionnaire.
Scores range from 0-100. A score of 0 corresponds to complete disability, while a score of 100 corresponds to no disability.
Measured: Between baseline and 4 weeks
Changes in Quality of Life, as assessed by the The Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire
Scores range from 0-100, with lower scores corresponding with a poorer Quality of Life. 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: Between baseline and 4 weeks
Echocardiographic changes, measured by left ventricle ejection fraction (LVEF)
Heart failure with reduced ejection fraction (HFrEF); LVEF ≤40%, Heart failure with mid-range ejection fraction (HFmrEF); LVEF 41-49%, Heart failure with preserved ejection fraction (HFpEF); LVEF ≥50%.
Measured: Between baseline and 4 weeks
Changes in cardiac output, measured using the echocardiographic measurements using velocity time interval.
Measured: Between baseline and 4 weeks
Laboratory changes of serum NT pro-BNP levels
Measured: Between baseline and 4 weeks
Questioannire physician whether ECV can be used to distinguish AF-specific from HF-specific symptoms
10-point likert scale
Measured: between baseline and 3 months
Time to Photoplethysmography (PPG)-based recurrence of AF (intervention arm).
Measured: Between baseline and 3 months
Changes in inflammatory markers
To study the association between inflammation and atrial fibrillation, we will measure serum proteins at two different time points, for both the intervention and control group. We will investigate whether inflammatory proteins are different in HF patients who returned to sinus rhythm (the intervention group), compared to patients with persistent atrial fibrillation (standard of care). Moreover, we will asses the effects of electrical cardioversion (intervention group) on plasma proteins over time.
Measured: Between baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M. Rienstra
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen, University Medical Center Groningen
- Responsible party
- Sponsor-investigator, M. Rienstra, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000942
- Sponsor's protocol ID
- DEEP-AF-HF
- Acronym
- DEEP-AF-HF
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms
- ClinicalTrials.gov ID
- NCT07000942
- Acronym / sponsor ID
- DEEP-AF-HF / DEEP-AF-HF
- Keywords
- Electrical cardioversion, Quality of Life (QoL), Treatment changes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- M. RienstraUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen, University Medical Center Groningen
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Jun 2025 (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.
Rationale:
The co-existence of Atrial Fibrillation (AF) and Heart Failure (HF) is associated with increased morbidity, mortality, and hospital admissions, significantly contributing to healthcare burden. Patients often experience overlapping symptoms, complicating identifying the disease primarily responsible for symptom burden. Electrical cardioversion (ECV) has been suggested to assess symptom status in sinus rhythm. However, the role of a diagnostic ECV in patients with AF and concomitant HF has not been established.
The hypothesis of this trial is that a diagnostic ECV can provide insight into AF-specific and HF-specific symptoms that can inform the physician and subsequently lead to treatment changes, as well as improve quality of life (QoL), and result changes in ejection fraction, cardiac output, and NT-proBNP levels.
Objective: To assess whether a diagnostic ECV results in more treatment changes after 3 months, compared to standard of care (no ECV).
Study design: This is an investigator initiated, randomized, open label with blinded endpoint evaluation, multi-centre, trial.
Study population: 112 patients with chronic HF and ECG confirmed persistent AF.
Trial intervention: Patients will be randomized in a 1:1 ratio to either an ECV or standard of care with pharmacological rate and/or rhythm control.
Main study parameters/endpoints:
The primary outcome: total number of treatment alterations by the physician during 3 months post intervention/randomization.
Secondary outcomes: Success rate of ECV, recurrences of AF at 4 weeks, QoL changes assessed by AFEQT and KCCQ score, echocardiographic changes (left ventricular ejection fraction (LVEF) and cardiac output (CO)), and laboratory changes (NT-proBNP) between baseline (pre-cardioversion) and 4 weeks (post-cardioversion). Whether the physician can distinguish AF from HF symptoms and whether ECV can be used as diagnostic tool.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a pragmatic trial, the study will be embedded within care according to current AF and HF guidelines, that includes ECV and rhythm and/or rate control, while acknowledging wide variability in local practises. The patients in the intervention arm will undergo a diagnostic ECV. Both groups will fill out questionnaires regarding QoL (baseline and 4 weeks) and have an echocardiogram at 4 weeks. A blinded endpoint committee will assess potential treatment alterations prescribed by the physician in both patient groups within 3 months. No harm is expected for this study as the intervention will be based on national guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical cardioversion (ECV) | Active comparator | Other: Electrical cardioversion (ECV) |
| Standard of Care (SoC) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients with age ≥ 18 years
- Diagnosis of HF ≥90 days prior to screening NYHA class ≥ 2 on guideline-directed medical therapy.
- ECG-confirmed AF/Atrial flutter at screening
- Received oral anti-coagulants for ≥ 3 weeks (DOAC, vitamin K antagonists with an INR between 2 and 3) prior to screening
- Patients eligible for both treatment strategies judged by the investigator and physician.
Key exclusion criteria (15 listed)
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- Inability to understand and sign informed consent form
- Hospitalization for acute HF or worsening HF ≤ 3 months prior to screening
- Heart rate during AF/ atrial flutter ≥ 110 bpm, despite optimal rate control therapy at screening
- Paroxysmal or permanent AF/atrial flutter
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 |
|---|---|---|
| Electrical cardioversion (ECV)Electrical cardioversion in patients with persistent atrial fibrillation and chronic heart failure | Other | Electrical cardioversion (ECV) |
Primary outcome
Total number of treatment alterations
Time frame: During 3 months post intervention/randomization
Total number of heart failure and/or atrial fibrillation treatment alterations by the physician
9 secondary outcomes
Success rate of the ECV
Time frame: At baseline
Changes in Quality of Life, as assessed by the Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) questionnaire.
Time frame: Between baseline and 4 weeks
Changes in Quality of Life, as assessed by the The Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire
Time frame: Between baseline and 4 weeks
Echocardiographic changes, measured by left ventricle ejection fraction (LVEF)
Time frame: Between baseline and 4 weeks
Changes in cardiac output, measured using the echocardiographic measurements using velocity time interval.
Time frame: Between baseline and 4 weeks
Laboratory changes of serum NT pro-BNP levels
Time frame: Between baseline and 4 weeks
Questioannire physician whether ECV can be used to distinguish AF-specific from HF-specific symptoms
Time frame: between baseline and 3 months
Time to Photoplethysmography (PPG)-based recurrence of AF (intervention arm).
Time frame: Between baseline and 3 months
Changes in inflammatory markers
Time frame: Between baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical cardioversion (ECV) in people with Atrial Fibrillation (AF) and Heart Failure (HF), run by M. Rienstra at 1 site in Netherlands.
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 15 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: opening soon, as of the sponsor's last update on 3 Jun 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. M. Rienstra (+31 050 3612355, m.rienstra@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of treatment alterations (time frame: During 3 months post intervention/randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.