Heart FailureCASTLE-HTxNCT04649801
Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation
A study testing Atrial fibrillation ablation in people with Heart Failure and Atrial Fibrillation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 15 May 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic paroxysmal or persistent AF (paroxysmal: ≥2 symptomatic or one documented AF episode lasting 30 seconds or more in the last 3 months; persistent: ≥1 documented episode in the last 3 months).
- Eligible for heart transplantation due to end-stage heart failure
- LV dysfunction with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment).
- NYHA class ≥ II.
- Indication for ICD therapy due to primary prevention.
- Dual chamber ICD with Home Monitoring capabilities already implanted.
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- The patient is willing and able to comply with the protocol and has provided written informed consent.
- Sufficient GPRS-network coverage in the patient's area.
- Age ≥ 18 years.
Who cannot join
- Documented left atrial diameter > 6 cm (parasternal long-axis view)
- Contraindication for chronic anticoagulation therapy or heparin
- Previous left heart ablation procedure for atrial fibrillation
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment
- Untreated hypothyroidism or hyperthyroidism
- Enrollment in another investigational drug or device study
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- Indication for cardiac resynchronization therapy
- Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
- Mental or physical inability to participate in the study
- Listed as "high urgent" for heart transplantation
- Cardiac assist device implanted
- Planned cardiovascular intervention
- Life expectancy ≤ 12 month
- Uncontrolled hypertension
- Requirement for dialysis due to end-stage renal failure
- Participation in another telemonitoring concept
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Bad Oeynhausen, 32545
About this study
Official title: Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx
Read the detailed description
CASTLE-HTx is a randomized evaluation of ablative treatment of AF in patients with severe left ventricular dysfunction who are candidates and eligible for HTx. The primary endpoint is the composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or LVAD implantation. The secondary study endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of HF requiring unplanned hospitalization, AF burden reduction, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, QoL, number of delivered implantable cardioverter-defibrillator (ICD) therapies, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, exercise tolerance, and percentage of right ventricular pacing. Ventricular myocardial tissue will be obtained from patients who will undergo LVAD implantation or HTx to assess the effect of catheter ablation on human HF myocardium.
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- Atrial fibrillation ablation
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| conventional | No intervention | Not described |
| interventional | Active comparator | Not described Receives: Procedure: Atrial fibrillation ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality or transplantation
composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2022
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649801
- Sponsor's protocol ID
- HDZ_ER002_CS
- Acronym
- CASTLE-HTx
- Status last verified
- Mar 2023
- First submitted
- 7 Oct 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boettger P, Moersdorf M, Sommer P, Marrouche NF, Costard-Jaeckle A, Crijns HJGM, Bergau L, Fox H, Hindricks G, Dagres N, Schramm R, Fink T, Khalaph M, Sciacca V, Didenko M, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sossalla S, Sohns C; CASTLE HTx Investigators. Cost-effectiveness of catheter ablation in end-stage heart failure with atrial fibrillation: Insights from CASTLE-HTx. Heart Rhythm. 2026 May 19:S1547-5271(26)02391-X. doi: 10.1016/j.hrthm.2026.05.024. Online ahead of print.
PubMed 42162774Sohns C, Fox H, Marrouche NF, Crijns HJGM, Costard-Jaeckle A, Bergau L, Hindricks G, Dagres N, Sossalla S, Schramm R, Fink T, El Hamriti M, Moersdorf M, Sciacca V, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sommer P; CASTLE HTx Investigators. Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation. N Engl J Med. 2023 Oct 12;389(15):1380-1389. doi: 10.1056/NEJMoa2306037. Epub 2023 Aug 27.
PubMed 37634135
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
- ClinicalTrials.gov ID
- NCT04649801
- Acronym / sponsor ID
- CASTLE-HTx / HDZ_ER002_CS
- Conditions
- Heart Failure, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 2 Dec 2020 (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.
CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx
Detailed description
CASTLE-HTx is a randomized evaluation of ablative treatment of AF in patients with severe left ventricular dysfunction who are candidates and eligible for HTx. The primary endpoint is the composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or LVAD implantation. The secondary study endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of HF requiring unplanned hospitalization, AF burden reduction, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, QoL, number of delivered implantable cardioverter-defibrillator (ICD) therapies, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, exercise tolerance, and percentage of right ventricular pacing. Ventricular myocardial tissue will be obtained from patients who will undergo LVAD implantation or HTx to assess the effect of catheter ablation on human HF myocardium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | No intervention | – |
| interventional | Active comparator | Procedure: Atrial fibrillation ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Symptomatic paroxysmal or persistent AF (paroxysmal: ≥2 symptomatic or one documented AF episode lasting 30 seconds or more in the last 3 months; persistent: ≥1 documented episode in the last 3 months).
- Eligible for heart transplantation due to end-stage heart failure
- LV dysfunction with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment).
- NYHA class ≥ II.
- Indication for ICD therapy due to primary prevention.
Key exclusion criteria (16 listed)
- Documented left atrial diameter > 6 cm (parasternal long-axis view)
- Contraindication for chronic anticoagulation therapy or heparin
- Previous left heart ablation procedure for atrial fibrillation
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment
- Untreated hypothyroidism or hyperthyroidism
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 |
|---|---|---|
| Atrial fibrillation ablationCatheter ablation | Procedure or surgery | interventional |
Primary outcome
Mortality or transplantation
Time frame: 24 months
composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 42162774Boettger P, Moersdorf M, Sommer P, Marrouche NF, Costard-Jaeckle A, Crijns HJGM, Bergau L, Fox H, Hindricks G, Dagres N, Schramm R, Fink T, Khalaph M, Sciacca V, Didenko M, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sossalla S, Sohns C; CASTLE HTx Investigators. Cost-effectiveness of catheter ablation in end-stage heart failure with atrial fibrillation: Insights from CASTLE-HTx. Heart Rhythm. 2026 May 19:S1547-5271(26)02391-X. doi: 10.1016/j.hrthm.2026.05.024. Online ahead of print.
- Derived from this study: PubMed 37634135Sohns C, Fox H, Marrouche NF, Crijns HJGM, Costard-Jaeckle A, Bergau L, Hindricks G, Dagres N, Sossalla S, Schramm R, Fink T, El Hamriti M, Moersdorf M, Sciacca V, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sommer P; CASTLE HTx Investigators. Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation. N Engl J Med. 2023 Oct 12;389(15):1380-1389. doi: 10.1056/NEJMoa2306037. Epub 2023 Aug 27.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation ablation in people with Heart Failure and Atrial Fibrillation, run by Heart and Diabetes Center North-Rhine Westfalia 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 17 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality or transplantation (time frame: 24 months). 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 NCT04649801, which also lists 2 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 17 May 2023.