Atrial FibrillationPFA-BreisgauNCT06156644
Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator
A study testing PFA in people with Atrial Fibrillation, run by University Hospital Freiburg.
Trial summary
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Dec 2026
- 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
- new onset atrial fibrillation
Who cannot join
- age <18 years
- previous left atrial ablation
- lack or withdrawal of written informed consent
- unable to receive ablation therapy
About this study
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. For 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled.
Read the detailed description
The principal safety and efficacy of PFA have been established in previous studies, showing low compli¬cation rates, short procedure times, and non-inferior/ superior efficiency compared to thermal abla¬tion.18, 19 However, current generators available for clinical practice are not generally designed to allow both non-thermal and thermal ablation in single shot settings. Moreover, modification of PFA sequences is not supported in commercially available systems. Flexible, multi-modal generators that allow one to conduct PFA or RF ablation using one and the same catheter would be highly desirable, from a clinical point of view, to allow for on-the-fly decision-making in view of individual patient requirements.
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. This generator will be CE marked in Q3/24. Upon completion of the ethical approval process in Q2/25, the 'first in human' study, exploring safety of the Stockert PFA generator will be started.
The trial will be a prospective single arm study at the UHZ Freiburg · Bad Krozingen and will recruit for 12 months and follow-up for 12 months, after a 3-months blanking period. 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled. Exclusion criteria will be age <18 years, previous left atrial ablation, and lack or withdrawal of written informed consent. Data acquisition will use an electronic case report form (RedCap Database). Procedures will be performed using standard operating procedures (SOP).
In short: ablations will be performed under deep analgo-sedation and/or general anaesthesia. Trans¬oesophageal echocardiography will be performed if patients present with either AF or atrial tachycardia (to exclude intracardiac thrombi) or in sinus rhythm (in patients with interrupted oral anticoagulation and CHA2DS2-VASc-Score ≥2). Atrial transseptal puncture will be performed for access to pulmonary veins (PV), using a fixed curve transseptal sheath and transseptal needle according to standard SOP. PFA catheters (FARAWAVE™, Boston Scientific) will be utilized, as in prior work with a commercial PFA system (FARAPULSE™, Boston Scientific) at the UHZ. At every PV antrum, 8 PFA-pulses will be delivered in 'flower' and 'basket' configurations (delivery of additional PFA-pulses will be at operator's discretion).
- Conditions
- Atrial Fibrillation
- Being tested
- PFA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFADevice
Ablation to treat trail fibrillation
| Study group | Role | What they receive |
|---|---|---|
| PFA strategy | Other | PFA will be performed based on a specific protocol Receives: Device: PFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of death
Primary endpoints focusing of the safety of the strategy
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Dirk Westermann, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156644
- Sponsor's protocol ID
- PFA-Breisgau
- Acronym
- PFA-Breisgau
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator
- ClinicalTrials.gov ID
- NCT06156644
- Acronym / sponsor ID
- PFA-Breisgau / PFA-Breisgau
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Dec 2023 (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.
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. For 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled.
Detailed description
The principal safety and efficacy of PFA have been established in previous studies, showing low compli¬cation rates, short procedure times, and non-inferior/ superior efficiency compared to thermal abla¬tion.18, 19 However, current generators available for clinical practice are not generally designed to allow both non-thermal and thermal ablation in single shot settings. Moreover, modification of PFA sequences is not supported in commercially available systems. Flexible, multi-modal generators that allow one to conduct PFA or RF ablation using one and the same catheter would be highly desirable, from a clinical point of view, to allow for on-the-fly decision-making in view of individual patient requirements.
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. This generator will be CE marked in Q3/24. Upon completion of the ethical approval process in Q2/25, the 'first in human' study, exploring safety of the Stockert PFA generator will be started.
The trial will be a prospective single arm study at the UHZ Freiburg · Bad Krozingen and will recruit for 12 months and follow-up for 12 months, after a 3-months blanking period. 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled. Exclusion criteria will be age <18 years, previous left atrial ablation, and lack or withdrawal of written informed consent. Data acquisition will use an electronic case report form (RedCap Database). Procedures will be performed using standard operating procedures (SOP).
In short: ablations will be performed under deep analgo-sedation and/or general anaesthesia. Trans¬oesophageal echocardiography will be performed if patients present with either AF or atrial tachycardia (to exclude intracardiac thrombi) or in sinus rhythm (in patients with interrupted oral anticoagulation and CHA2DS2-VASc-Score ≥2). Atrial transseptal puncture will be performed for access to pulmonary veins (PV), using a fixed curve transseptal sheath and transseptal needle according to standard SOP. PFA catheters (FARAWAVE™, Boston Scientific) will be utilized, as in prior work with a commercial PFA system (FARAPULSE™, Boston Scientific) at the UHZ. At every PV antrum, 8 PFA-pulses will be delivered in 'flower' and 'basket' configurations (delivery of additional PFA-pulses will be at operator's discretion).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm
| Arm | Type | Receives |
|---|---|---|
| PFA strategy | Other | Device: PFAPFA will be performed based on a specific protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- new onset atrial fibrillation
Key exclusion criteria (4 listed)
- age <18 years
- previous left atrial ablation
- lack or withdrawal of written informed consent
- unable to receive ablation therapy
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 |
|---|---|---|
| PFAAblation to treat trail fibrillation | Device | PFA strategy |
Primary outcome
number of death
Time frame: 12 month
Primary endpoints focusing of the safety of the strategy
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 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PFA in people with Atrial Fibrillation, run by University Hospital Freiburg.
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 1 inclusion and 4 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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 death (time frame: 12 month). 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 Jan 2024.