Persistent Atrial FibrillationPersAFOne IINCT05152966
Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)
A study testing Ablation in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in Czechia.
Trial summary
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Sep 2021to 1 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- AF that is:
- Paroxysmal (longest AF episode < 7days)
- Longstanding (has persisted > 12 months or that does not respond to cardioversion if < 12 months)
- Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
Show all 49Show fewer
- Any of the following cardiac procedures, implants or conditions:
- Clinically significant arrhythmias other than AF, AFL or AT
- Hemodynamically significant valvular disease
- Prosthetic heart valve
- NYHA Class III or IV CHF
- Previous endocardial or epicardial ablation or surgery for AF
- Atrial or ventricular septal defect closure
- Atrial myxoma
- Left atrial appendage device or occlusion
- Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
- Significant or symptomatic hypotension
- Bradycardia or chronotropic incompetence
- History of pericarditis
- History of rheumatic fever
- History of congenital heart disease with any residual anatomic or conduction abnormality
- Any of the following within 3 months prior toenrollment:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
- Heart failure hospitalization
- Stroke or TIA
- Clinically significant bleeding
- Pericarditis or pericardial effusion
- Left atrial thrombus
- History of blood clotting or bleeding abnormalities.
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Contraindications to CT or MRI
- Sensitivity to contrast media not controlled by premedication
- Women of childbearing potential who are pregnant, lactating or not using birth control
- Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to
- Body mass index (BMI) > 40
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
- Renal insufficiency with an estimated creatinine clearance <30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- Active malignancy or history of treated cancer within 24 months of enrollment
- Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- Clinically significant infection
- Predicted life expectancy less than one year
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
- Current or anticipated enrollment in any other clinical study
- Employment by FARAPULSE or the same hospital department or office of any investigator, or a family member of any of the preceding groups.
- Use of amiodarone after day of index ablation procedure. Patients will cease use of amiodarone on or before the date of the index ablation procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PersAFOne II(Pronounced Per-'Se-fa-nē 2); Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL
Read the detailed description
This is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Ablation using the FARAPULSE™ Cardiac Ablation System Plus
| Study group | Role | What they receive |
|---|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation | Experimental | Ablation using FARAPULSE™ Cardiac Ablation System Plus Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up.
Measured: 7 days
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC).
Measured: 12 Months
Acute Procedural Success; Acute Vein Succes
Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure)
Measured: Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start16 Sep 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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.
- Other trials for Persistent 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
- 20 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
- NCT05152966
- Sponsor's protocol ID
- CS1335
- Acronym
- PersAFOne II
- Status last verified
- Feb 2024
- First submitted
- 15 Nov 2021
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PersAFOne II(Pronounced Per-'Se-fa-nē 2); Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05152966
- Acronym / sponsor ID
- PersAFOne II / CS1335
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Posted 31 Jan 2024
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 this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL
Detailed description
This is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation | Experimental | Device: AblationAblation using FARAPULSE™ Cardiac Ablation System Plus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (49 listed)
- Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- AF that is:
- Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
- Any of the following cardiac procedures, implants or conditions:
- Any of the following within 3 months prior toenrollment:
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 |
|---|---|---|
| AblationAblation using the FARAPULSE™ Cardiac Ablation System Plus | Device | FARAPULSE™ Endocardial Cardiac Ablation |
Primary outcome
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
Time frame: 7 days
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up.
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
Time frame: 12 Months
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC).
Acute Procedural Success; Acute Vein Succes
Time frame: Index Procedure
Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Ablation in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in Czechia.
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 0 inclusion and 49 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 28 Feb 2024. 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 Czechia. 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 31 Jan 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?
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs (time frame: 7 days). The study lists 3 primary outcomes in all. 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 28 Feb 2024.