Atrial FibrillationPhase 4CABA-HFPEFNCT05508256
CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
A Phase 4 study testing CE-marked Catheter Ablation in people with Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
- What is being tested?
- CE-marked Catheter Ablation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,548 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2023to Jul 2027
- Phase
- Phase 4
- 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
- Age ≥18 years
- Signed written informed consent
- Clinical evidence of symptomatic heart failure (NYHA Class II-III)
- Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG)
- Left ventricular ejection fraction (LVEF) 40-49%
- OR
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- LVEF ≥ 50% with at least one of the following HFpEF echocardiography findings (any local measurement made during the screening epoch):
- LA enlargement defined by at least 1 of the following: LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml/m2
- Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1 cm or relative wall thickness >0.42)
- Patients with at least 1 of the following:
- HF hospitalization (defined as HF listed as the major reason for hospitalization) within 6 months prior to screening visit and NT-proBNP >200 pg/ml for patients in sinus rhythm (SR) or >600 pg/ml for patients in AF at the time of blood sampling
- NT-proBNP >300 pg/ml for patients in SR or >900 pg/ml for patients in AF on screening ECG
Who cannot join
- Patient is unable or unwilling to provide infomed consent
- Patient is not suitable for rhythm control of AF
- Previous left atrial CA or surgical therapy of AF
- Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
- Valvular heart disease needing interventional or surgical treatment within 3 months
- Heart surgery planned within 3 months
Show all 14Show fewer
- Prior heart transplant or listed for heart transplant or cardiac assist device implantation
- Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled)
- Patient has absolute contra-indication to oral anticoagulation
- Any disease that limits life expectancy to less than 1 year
- Active systemic infection (after successful treatment of infection, patients may be enrolled)
- Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index < 1%)
- Patient is included in another clinical trial
- Inability to comply with the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine Berlin, Campus Virchow Klinikum
Berlin, 13353
Abdul Parwani, Dr., 004930450565383, caba_hfpef@charite.de
About this study
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Read the detailed description
HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.
Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.
No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.
- Conditions
- Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
- Being tested
- CE-marked Catheter Ablation
- Keywords
- atrial fibrillation, heart failure, catheter ablation, medial therapy
- 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.
CE-marked Catheter AblationDevice
Once patients have been randomized to the catheter ablation (CA) group, the ablation procedure must be performed within 4 weeks. CA will initially aim at pulmonary vein isolation.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation | Active comparator | Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Patients assigned to rhythm control group will be treated with catheter ablation as first line therapy to restore and maintain sinus rhythm, additionally to the therapeutic recommendations of the current ESC guidelines for the management of atrial fibrillation (AF) and the current ESC Heart Failure (HF) guidelines. Receives: Device: CE-marked Catheter Ablation |
| Usual Medical Care | No intervention | Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Subjects randomized to usual care will be treated according to current ESC guidelines for the management of AF and current ESC HF guidelines. Usual care of AF in the context of CABA-HFPEF consists of an initial treatment limited to rate control in addition to adequate antithrombotic therapy, typically oral anticoagulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome.
Measured: Estimated first patient in to last patient out 48 months.
Secondary outcomes (13)
All-cause mortality
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Cardiovascular death
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Stroke
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Unplanned hospitalization for atrial arrhythmia
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Total (first and recurrent) planned and unplanned cardiovascular hospitalizations
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Nights spent in hospital
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Days alive and out of hospital
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Atrial fibrillation burden (percentage of AF at 12 months FU Holter ECG)
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in left ventricular ejection fraction at 12 months FU
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in NYHA class at 12 months FU
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in EHRA score at 12 months FU
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in quality of life at 12 months FU
Measured: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study startMar 2023 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The CABA-HFPEF is an investigator-initiated, prospective, parallel-group, randomized, open, blinded endpoint assessment, interventional multicenter strategy trial. CABA-HFPEF compares two treatment strategies that employ established therapies within their approved indications.
- Masking
- None (open label)
- Enrolment
- 1,548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Kompetenznetz Vorhofflimmern e.V. (AFNET), Boston Scientific Corporation
- Responsible party
- Principal investigator, Abdul Parwani, Charite University, Berlin, Germany
- Investigators
- Abdul Parwani, Dr., Principal investigator, Head of Electrophysiology; Charité University Medicine Berlin, CVKPaulus Kirchhof, Prof. Dr., Study chair, Director Department of Cardiology, Heart and Vascular Center University Hamburg EppendorfStefan Kääb, Prof. Dr., Study chair, Department of Cardiology, Ludwig-Maximilians-University Hospital MunichTim Friede, Prof. Dr., Study chair, Departement of Medical Statistics, University Medical Center GöttingenRoland Tilz, Prof. Dr., Study chair, Head of Electrophysiology Department, University Hospital LübeckBurkert Pieske, Prof. Dr., Study chair, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508256
- Sponsor's protocol ID
- CABA-HFPEF-DZHK27
- Acronym
- CABA-HFPEF
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05508256
- Acronym / sponsor ID
- CABA-HFPEF / CABA-HFPEF-DZHK27
- Conditions
- Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
- Keywords
- atrial fibrillation, heart failure, catheter ablation, medial therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,548 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Kompetenznetz Vorhofflimmern e.V. (AFNET), Boston Scientific Corporation
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Aug 2022 (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.
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Detailed description
HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.
Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.
No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The CABA-HFPEF is an investigator-initiated, prospective, parallel-group, randomized, open, blinded endpoint assessment, interventional multicenter strategy trial. CABA-HFPEF compares two treatment strategies that employ established therapies within their approved indications.
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | Active comparator | Device: CE-marked Catheter AblationSymptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Patients assigned to rhythm control group will be treated with catheter ablation as first line therapy to restore and maintain sinus rhythm, additionally to the therapeutic recommendations of the current ESC guidelines for the management of atrial fibrillation (AF) and the current ESC Heart Failure (HF) guidelines. |
| Usual Medical Care | No intervention | –Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Subjects randomized to usual care will be treated according to current ESC guidelines for the management of AF and current ESC HF guidelines. Usual care of AF in the context of CABA-HFPEF consists of an initial treatment limited to rate control in addition to adequate antithrombotic therapy, typically oral anticoagulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years
- Signed written informed consent
- Clinical evidence of symptomatic heart failure (NYHA Class II-III)
- Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG)
- Left ventricular ejection fraction (LVEF) 40-49%
Key exclusion criteria (14 listed)
- Patient is unable or unwilling to provide infomed consent
- Patient is not suitable for rhythm control of AF
- Previous left atrial CA or surgical therapy of AF
- Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
- Valvular heart disease needing interventional or surgical treatment within 3 months
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 |
|---|---|---|
| CE-marked Catheter AblationOnce patients have been randomized to the catheter ablation (CA) group, the ablation procedure must be performed within 4 weeks. CA will initially aim at pulmonary vein isolation. | Device | Catheter Ablation |
Primary outcome
The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome.
Time frame: Estimated first patient in to last patient out 48 months.
13 secondary outcomes
All-cause mortality
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Cardiovascular death
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Stroke
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Unplanned hospitalization for atrial arrhythmia
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Total (first and recurrent) planned and unplanned cardiovascular hospitalizations
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Nights spent in hospital
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Days alive and out of hospital
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Atrial fibrillation burden (percentage of AF at 12 months FU Holter ECG)
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in left ventricular ejection fraction at 12 months FU
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in NYHA class at 12 months FU
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in EHRA score at 12 months FU
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
Change in quality of life at 12 months FU
Time frame: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
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 6 Mar 2023.
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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.
Abdul Parwani, Dr. principal investigator
Head of Electrophysiology; Charité University Medicine Berlin, CVK
Paulus Kirchhof, Prof. Dr. study chair
Director Department of Cardiology, Heart and Vascular Center University Hamburg Eppendorf
Stefan Kääb, Prof. Dr. study chair
Department of Cardiology, Ludwig-Maximilians-University Hospital Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CE-marked Catheter Ablation in people with Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction, run by Charite University, Berlin, Germany at 1 site in Germany.
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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 6 Mar 2023. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Abdul Parwani, Dr. (+4930450565383, caba_hfpef@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome. (time frame: Estimated first patient in to last patient out 48 months.). 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 6 Mar 2023.