Atrial FibrillationNCT07181291
Pulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure
An observational study of Atrial Fibrillation and Heart Failure With Reduced Ejection Fraction, run by St. Josefs-Hospital Wiesbaden GmbH at 12 sites in 2 countries.
Trial summary
Patients with atrial fibrillation (AF) and heart failure with reduced left ventricular ejection fraction (HFrEF) are at particularly high cardiovascular risk. Rhythm-control by means of catheter-based pulmonary vein isolation (PVI) reduces all-cause mortality and rehospitalization for worsening heart failure in these… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- PVI
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Sep 2025to 1 Feb 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation and heart failure (LVEF ≤ 40%)
Who may be able to join
- Patients with paroxysmal or persistent AF and echocardiographically confirmed HFrEF (LVEF ≤ 40%)
- Patients who underwent their first PVI using pulsed field or cryoballoon ablation as part of clinical routine
- Patients with regular follow-up via 12-lead ECG or Holter ECG following PVI
- Patients with at least three months of follow-up
Who cannot join
- Patients who did not undergo pulsed field or cryoballoon ablation for first-time PVI
- Patients with LVEF > 40%
- Patients who declined the use of their data during initial collection
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Germany10 sites
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim
Vivantes Klinikum am Urban
Berlin
Evangelisches Krankenhaus Düsseldorf
Düsseldorf
Universitätsklinikum Frankfurt am Main
Frankfurt am Main
Klinikum Fürth
Fürth
Evangelisches Krankenhaus Hagen-Haspe
Hagen
Universitätsklinikum Hamburg-Eppendorf
Hamburg-Eppendorf
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Heidelberg
Heidelberg
St. Josefs-Hospital Wiesbaden
Wiesbaden
Canada2 sites
Montreal Heart Institute
Montreal, Quebec
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Pulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure (a Propensity Score Matched Comparison)
Patients with atrial fibrillation (AF) and heart failure with reduced left ventricular ejection fraction (HFrEF) are at particularly high cardiovascular risk. Rhythm-control by means of catheter-based pulmonary vein isolation (PVI) reduces all-cause mortality and rehospitalization for worsening heart failure in these patients. Considering the globally increasing use of the novel "pulsed-field ablation", it is necessary to determine whether this technique can be performed with the same safety and efficacy as the established cryoballoon ablation (CRYO) in this critically ill patient population.
This retrospective, international, multicenter study compares the efficacy and safety of PFA versus CRYO in patients with AF and HFrEF (LVEF ≤40%) undergoing a first-time PVI-only procedure.
Using propensity-score matching to minimize selection bias, the study will retrospectively evaluate whether a non-thermal PFA approach is non-inferior to the established thermal CRYO technique regarding rhythm control, while comparing procedural safety and efficiency in this high-risk population. Non-inferiority is tested against the assumption of a 12-month recurrence rate of 30% with a prespecified non-inferiority margin of 12% (corresponding to a hazard ratio of 1.53).
- Being tested
- PVI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIProcedure or surgery
pulmonary-vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon pulmonary-vein isolation | Electrical isolation of the pulmonary-veins using cryoenergy Receives: Procedure: PVI | |
| Pulsed field pulmonary-vein isolation | Electrical isolation of the pulmonary-veins using pulsed field energy Receives: Procedure: PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention
First documented clinical recurrence of any atrial arrhythmia
Measured: 12 months
Secondary outcomes (4)
Number of patients with a rehospitalization (≥ 1 night) due to atrial arrhythmia/ re-ablation or electrical cardioversion starting from day 1 post index procedure
Measured: 12 months
Number of patients with a rehospitalization (≥ 1 night) due to worsening heart failure
Measured: 12 months
Death from any cause
Measured: 12 months
Number of subjects with procedure-associated complications
Death, Major bleeding (criteria per Bleeding Academic Research Consortium ≥2, treatment-requiring groin complications (including AV fistula, aneurysm, or dissection), pericardial effusion/tamponade, non-fatal stroke/transient ischemic, attack, temporary or persistent phrenic nerve palsy, homeless
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2025
- Study completion1 Feb 2026
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.
- 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
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim Ehrlich, MD, Principal investigator, St. Josefs-Hospital Wiesbaden GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181291
- Sponsor's protocol ID
- PFA vs CRYO for AF-HFrEF
- Status last verified
- Feb 2026
- First submitted
- 11 Sep 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure (a Propensity Score Matched Comparison)
- ClinicalTrials.gov ID
- NCT07181291
- Acronym / sponsor ID
- PFA vs CRYO for AF-HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 18 Sep 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.
Patients with atrial fibrillation (AF) and heart failure with reduced left ventricular ejection fraction (HFrEF) are at particularly high cardiovascular risk. Rhythm-control by means of catheter-based pulmonary vein isolation (PVI) reduces all-cause mortality and rehospitalization for worsening heart failure in these patients. Considering the globally increasing use of the novel "pulsed-field ablation", it is necessary to determine whether this technique can be performed with the same safety and efficacy as the established cryoballoon ablation (CRYO) in this critically ill patient population.
This retrospective, international, multicenter study compares the efficacy and safety of PFA versus CRYO in patients with AF and HFrEF (LVEF ≤40%) undergoing a first-time PVI-only procedure.
Using propensity-score matching to minimize selection bias, the study will retrospectively evaluate whether a non-thermal PFA approach is non-inferior to the established thermal CRYO technique regarding rhythm control, while comparing procedural safety and efficiency in this high-risk population. Non-inferiority is tested against the assumption of a 12-month recurrence rate of 30% with a prespecified non-inferiority margin of 12% (corresponding to a hazard ratio of 1.53).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon pulmonary-vein isolation | – | Procedure: PVIElectrical isolation of the pulmonary-veins using cryoenergy |
| Pulsed field pulmonary-vein isolation | – | Procedure: PVIElectrical isolation of the pulmonary-veins using pulsed field energy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation and heart failure (LVEF ≤ 40%)
Key inclusion criteria (4 listed)
- Patients with paroxysmal or persistent AF and echocardiographically confirmed HFrEF (LVEF ≤ 40%)
- Patients who underwent their first PVI using pulsed field or cryoballoon ablation as part of clinical routine
- Patients with regular follow-up via 12-lead ECG or Holter ECG following PVI
- Patients with at least three months of follow-up
Key exclusion criteria (3 listed)
- Patients who did not undergo pulsed field or cryoballoon ablation for first-time PVI
- Patients with LVEF > 40%
- Patients who declined the use of their data during initial collection
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 |
|---|---|---|
| PVIpulmonary-vein isolation | Procedure or surgery | Cryoballoon pulmonary-vein isolation, Pulsed field pulmonary-vein isolation |
Primary outcome
Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention
Time frame: 12 months
First documented clinical recurrence of any atrial arrhythmia
4 secondary outcomes
Number of patients with a rehospitalization (≥ 1 night) due to atrial arrhythmia/ re-ablation or electrical cardioversion starting from day 1 post index procedure
Time frame: 12 months
Number of patients with a rehospitalization (≥ 1 night) due to worsening heart failure
Time frame: 12 months
Death from any cause
Time frame: 12 months
Number of subjects with procedure-associated complications
Time frame: 30 days
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 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.
Joachim Ehrlich, MD principal investigator
St. Josefs-Hospital Wiesbaden GmbH
12 sites in 2 countries: 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 With Reduced Ejection Fraction, run by St. Josefs-Hospital Wiesbaden GmbH at 12 sites in 2 countries.
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 4 inclusion and 3 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Canada. 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?
Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention (time frame: 12 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 13 Feb 2026.