Paroxysmal Atrial FibrillationFARA-FreedomNCT05072964
The FARAPULSE FARA-Freedom Trial
A study testing FARAPULSE Pulsed Field Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 13 sites in 6 countries.
Trial summary
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- FARAPULSE Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 21 Dec 2021to 19 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND
- At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date.
- Age 18 years or older
- Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active antiarrhythmic drug (AAD) for rhythm control.
- Willing and Capable of providing Informed Consent to undergo study procedures AND
- Participate in all examinations and follow-up visits and tests associated with this clinical study
Who cannot join
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Body Mass Index (BMI) >45.0
Show all 31Show fewer
- Anteroposterior Left Atrial diameter > 5.5 cm by transthoracic echocardiography (TTE)/ intracardiac imaging (ICE)
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
- Myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angiography (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- Unstable angina
- Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) < 35%
- 2º (Type II) or 3º atrioventricular block
- Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Hypertrophic cardiomyopathy
- Active Systemic infection
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- Any woman known to be pregnant
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Severe lung disease, pulmonary hypertension, or any lung disease associated with chronic abnormal blood gases or requiring supplemental oxygen
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- Active malignancy, or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
- Life expectancy less than one (1) year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study (data collection for registries or retrospective studies is permitted)
- Unwilling or unable to comply fully with study procedures and follow-up
- Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements
- Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea or active alcohol abuse
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Germany4 sites
Heart- and Diabetescenter NRW
Bad Oeynhausen
CCB Frankfurt
Frankfurt, 60431
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Asklepios-Hamburg,Germany
Hamburg
Czechia3 sites
Neuron Medical
Brno
Nemocnice Na Homolce
Prague, 150 30
IKEM Cardiac Center
Prague
About this study
Official title: The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
Read the detailed description
The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure.
The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 ~ 36 months of follow-up post-pulsed field ablation procedure.
The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34~36 months of follow-up post-pulsed field ablation procedure.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- FARAPULSE Pulsed Field Ablation System
- Keywords
- Catheter Ablation, Pulmonary Vein Isolation (PVI), Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia, Pulsed Field Ablation, Cavo-tricuspid isthmus, Anti-arrhythmic drugs, Atrial Fibrillation Drugs, Cardiac Arrhythmias, Cardiac Ablation, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE Pulsed Field Ablation SystemDevice
Also called Ablation catheters indicated for Paroxysmal Atrial Fibrillation
A pulmonary vein isolation will be performed using catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Other | Ablation using the FARAPULSE Pulsed Field Ablation System Receives: Device: FARAPULSE Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD).
Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure
Measured: 12 Months
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months
To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)
Measured: 12 Months
Secondary outcomes (2)
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE
Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event.
Measured: 12 Months
Additional Performance Analyses: Acute Procedural Success
Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start21 Dec 2021
- Primary completion12 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072964
- Sponsor's protocol ID
- CS1169
- Acronym
- FARA-Freedom
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Metzner A, Fiala M, Vijgen J, Ouss A, Gunawardene M, Hansen J, Kautzner J, Schmidt B, Duytschaever M, Reichlin T, Blaauw Y, Sommer P, Vanderper A, Achyutha AB, Johnson M, Raybuck JD, Neuzil P. Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study. Europace. 2024 Mar 1;26(3):euae053. doi: 10.1093/europace/euae053.
PubMed 38385529
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05072964
- Acronym / sponsor ID
- FARA-Freedom / CS1169
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Catheter Ablation, Pulmonary Vein Isolation (PVI), Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia, Pulsed Field Ablation, Cavo-tricuspid isthmus, Anti-arrhythmic drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
Detailed description
The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure.
The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 ~ 36 months of follow-up post-pulsed field ablation procedure.
The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34~36 months of follow-up post-pulsed field ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Other | Device: FARAPULSE Pulsed Field Ablation SystemAblation using the FARAPULSE Pulsed Field Ablation System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND
- At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date.
- Age 18 years or older
- Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active antiarrhythmic drug (AAD) for rhythm control.
Key exclusion criteria (31 listed)
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
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 |
|---|---|---|
| FARAPULSE Pulsed Field Ablation SystemAlso: Ablation catheters indicated for Paroxysmal Atrial FibrillationA pulmonary vein isolation will be performed using catheter ablation | Device | FARAPULSE Pulsed Field Ablation System |
Primary outcome
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Time frame: 12 Months
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months
Time frame: 12 Months
To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)
2 secondary outcomes
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE
Time frame: 12 Months
Additional Performance Analyses: Acute Procedural Success
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38385529Metzner A, Fiala M, Vijgen J, Ouss A, Gunawardene M, Hansen J, Kautzner J, Schmidt B, Duytschaever M, Reichlin T, Blaauw Y, Sommer P, Vanderper A, Achyutha AB, Johnson M, Raybuck JD, Neuzil P. Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study. Europace. 2024 Mar 1;26(3):euae053. doi: 10.1093/europace/euae053.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FARAPULSE Pulsed Field Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 13 sites in 6 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 7 inclusion and 31 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Czechia, Belgium, Netherlands, Denmark and 1 more country. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 NCT05072964, which also lists 1 linked publication.
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 Oct 2024.