Atrial FibrillationSPECTRA-AFNCT07788989
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
A study testing VARIPULSE Catheter System (PVI) and VARIPULSE Catheter System (PVI and PWI) in people with Atrial Fibrillation, run by Biosense Webster, Inc..
Trial summary
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- VARIPULSE Catheter System (PVI) and VARIPULSE Catheter System (PVI and PWI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2027to 29 Mar 2030
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has been diagnosed with either atrial fibrillation (AF) subtype (paroxysmal (AF episodes that start suddenly and typically last less than 7 days, often resolving in 24 hours) or persistent (AF lasting more than 7 days in duration and less than 365 days in duration, documented by )):
- A physician's note documenting diagnosis of symptomatic PAF/PsAF, as defined above AND
- PAF: At least one (1) AF episode electrocardiographically documented within 12 months prior to enrollment
- PsAF: Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be more than (>) 365 days prior to enrollment) OR A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
- Participant is aged 18-80 years at the time of informed consent
- Participant is willing and capable of providing informed consent
- Participant is able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- Participant has continuous AF > 365 days (longstanding persistent AF)
- Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, et cetera)
- Participant has previous surgical or catheter ablation for AF
- Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and wolff-parkinson-white)
- Participant has severe dilatation of the LA (LAD > 50 millimeter [mm]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
- Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
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- Participant has severely compromised left ventricular ejection fraction (LVEF < 40 percent [%]) confirmed by imaging performed within 180 days prior to enrollment
- Participant has uncontrolled heart failure or new york heart association (NYHA) Class III or IV
- Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
- Participant has had a thromboembolic event (including transient ischemic attack [TIA]) within 180 prior to enrollment
- Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within 60 days prior to enrollment
- Participant has had coronary artery bypass grafting (CABG) surgery within 180 days prior to enrollment
- Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement, and presence of a prosthetic valve)
- Participant has had unstable angina within 6 months prior to enrollment
- Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
- Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Participant has a significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
- Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
- Participant has a pre-existing hemi-diaphragmatic paralysis
- Participant has an acute illness, active systemic infection, or sepsis
- Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to (>=) 60 milliliter per beat (mL/beat), regurgitant fraction >= 50%, and/or effective regurgitant orifice area >=0.40 centimeter square [cm^2])
- Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, et cetera.) (this exclusion does not include coronary stents, implanted pacemakers, implantable cardioverter-defibrillators (ICD), and an implantable loop recorders (ILR))
- Participant has a condition that precludes vascular access (such as inferior vena cava (IVC) filter)
- Participant is currently enrolled in another investigational device or drug study
- Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
- Participant has a life expectancy less than 365 days
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High-Density Atrial Mapping After Pulsed Field Ablation (PFA): Development of an Algorithm to Predict Atrial Fibrillation (AF) Burden in Participants With Paroxysmal AF (PAF) and Persistent AF (PsAF) Treated With the VARIPULSE™ PFA Catheter
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).
- Conditions
- Atrial Fibrillation
- Being tested
- VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIPULSE Catheter System (PVI)Device
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
VARIPULSE Catheter System (PVI and PWI)Device
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal Atrial Fibrillation (PAF) | Experimental | Participants with symptomatic paroxysmal atrial fibrillation (PAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) utilizing the VARIPULSE catheter as per the device Instructions for Use (IFU). Receives: Device: VARIPULSE Catheter System (PVI) |
| Persistent Atrial Fibrillation (PsAF) | Experimental | Participants with symptomatic persistent atrial fibrillation (PsAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) and posterior wall isolation (PWI) utilizing the VARIPULSE catheter as per the device IFU. Receives: Device: VARIPULSE Catheter System (PVI and PWI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Early Onset Primary Adverse Events (PAEs)
PAEs include early onset AEs such as:
- Esophageal perforating complications
- Phrenic nerve paralysis (PNP; permanent)
- Cardiac tamponade/perforation
- Pulmonary vein stenosis (PVS)
- Death (device or procedure related)
- Stroke/ cerebrovascular accident (CVA)
- Major vascular access complication/bleeding
- Thromboembolism
- Myocardial Infarction (MI)
- Transient ischemic attack (TIA)
- Pericarditis
- Pulmonary edema (respiratory insufficiency)
- Heart block
- Vagal nerve injury/ gastroparesis
Measured: Up to 7 days post-procedure
Percentage of Participants With Residual Atrial Arrhythmia (AA) Burden Based on ILR Arrhythmia Monitoring
Percentage of residual AA burden will be calculated as AA episodes over the monitoring time during the effectiveness evaluation period. Participants with residual AA burden less than or equal to (<=) 0.1% and freedom from the following failure modes will be considered a success
- Acute procedural failure
- Repeat ablation failure
- Surgical treatment for atrial fibrillation (AF)/atrial tachycardia (AT)/atrial flutter (AFL) after the index ablation procedure
- Non-study catheter (NSC) failure
- Antiarrhythmic Drug (AAD) failure or any direct current (DC) cardioversion (DCCV) procedure during the evaluation period.
Measured: Day 61 up to Day 365 post-procedure
Secondary outcomes (5)
Change in Quality of Life (QOL) As Assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Measured: Baseline to 12 months post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=60 minutes on Implantable Loop Recorders [ILR])
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or >=60 minutes on ILR arrhythmia monitoring) during the post-blanking period will be reported.
Measured: Day 61 up to Day 365 post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=30 seconds on ILR)
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or >=30 seconds on ILR arrhythmia monitoring) during the post-blanking period.
Measured: Day 61 up to Day 365 post-procedure
Number of Participants with Residual AA Burden <=0.1%
Number of participants with residual AA burden <=0.1% in the post-blanking period, without any additional failure modes will be reported.
Measured: Day 61 up to Day 365 post-procedure
Percentage of Residual AA Burden
Percentage of residual AA burden in the post-blanking period without any additional failure modes will be reported.
Measured: Day 61 up to Day 365 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start14 Apr 2027 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion29 Mar 2030 (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.
- More trials run by Biosense Webster, Inc.The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc. Clinical Trial, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788989
- Sponsor's protocol ID
- BWI202524
- Other IDs
- BWI202524
- Acronym
- SPECTRA-AF
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Density Atrial Mapping After Pulsed Field Ablation (PFA): Development of an Algorithm to Predict Atrial Fibrillation (AF) Burden in Participants With Paroxysmal AF (PAF) and Persistent AF (PsAF) Treated With the VARIPULSE™ PFA Catheter
- ClinicalTrials.gov ID
- NCT07788989
- Acronym / sponsor ID
- SPECTRA-AF / BWI202524
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2027 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 27 Aug 2026 (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.
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal Atrial Fibrillation (PAF) | Experimental | Device: VARIPULSE Catheter System (PVI)Participants with symptomatic paroxysmal atrial fibrillation (PAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) utilizing the VARIPULSE catheter as per the device Instructions for Use (IFU). |
| Persistent Atrial Fibrillation (PsAF) | Experimental | Device: VARIPULSE Catheter System (PVI and PWI)Participants with symptomatic persistent atrial fibrillation (PsAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) and posterior wall isolation (PWI) utilizing the VARIPULSE catheter as per the device IFU. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has been diagnosed with either atrial fibrillation (AF) subtype (paroxysmal (AF episodes that start suddenly and typically last less than 7 days, often resolving in 24 hours) or persistent (AF lasting more than 7 days in duration and less than 365 days in duration, documented by )):
- Participant is aged 18-80 years at the time of informed consent
- Participant is willing and capable of providing informed consent
- Participant is able and willing to comply with all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (27 listed)
- Participant has continuous AF > 365 days (longstanding persistent AF)
- Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, et cetera)
- Participant has previous surgical or catheter ablation for AF
- Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and wolff-parkinson-white)
- Participant has severe dilatation of the LA (LAD > 50 millimeter [mm]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
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 |
|---|---|---|
| VARIPULSE Catheter System (PVI)VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure. | Device | Paroxysmal Atrial Fibrillation (PAF) |
| VARIPULSE Catheter System (PVI and PWI)VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure. | Device | Persistent Atrial Fibrillation (PsAF) |
Primary outcome
Number of Participants with Early Onset Primary Adverse Events (PAEs)
Time frame: Up to 7 days post-procedure
PAEs include early onset AEs such as: * Esophageal perforating complications * Phrenic nerve paralysis (PNP; permanent) * Cardiac tamponade/perforation * Pulmonary vein stenosis (PVS) * Death (device or procedure related) * Stroke/ cerebrovascular accident (CVA) * Major vascular access complication/bleeding * Thromboembolism * Myocardial Infarction (MI) * Transient ischemic attack (TIA) * Pericarditis * Pulmonary edema (respiratory insufficiency) * Heart block * Vagal nerve injury/ gastroparesis
Percentage of Participants With Residual Atrial Arrhythmia (AA) Burden Based on ILR Arrhythmia Monitoring
Time frame: Day 61 up to Day 365 post-procedure
Percentage of residual AA burden will be calculated as AA episodes over the monitoring time during the effectiveness evaluation period. Participants with residual AA burden less than or equal to (<=) 0.1% and freedom from the following failure modes will be considered a success * Acute procedural failure * Repeat ablation failure * Surgical treatment for atrial fibrillation (AF)/atrial tachycardia (AT)/atrial flutter (AFL) after the index ablation procedure * Non-study catheter (NSC) failure * Antiarrhythmic Drug (AAD) failure or any direct current (DC) cardioversion (DCCV) procedure during the evaluation period.
5 secondary outcomes
Change in Quality of Life (QOL) As Assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
Time frame: Baseline to 12 months post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=60 minutes on Implantable Loop Recorders [ILR])
Time frame: Day 61 up to Day 365 post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=30 seconds on ILR)
Time frame: Day 61 up to Day 365 post-procedure
Number of Participants with Residual AA Burden <=0.1%
Time frame: Day 61 up to Day 365 post-procedure
Percentage of Residual AA Burden
Time frame: Day 61 up to Day 365 post-procedure
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 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Biosense Webster, Inc. Clinical Trial study director
Biosense Webster, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing VARIPULSE Catheter System (PVI) and VARIPULSE Catheter System (PVI and PWI) in people with Atrial Fibrillation, run by Biosense Webster, Inc..
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 27 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 Nov 2026. 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?
Contact Andrew Oliver (+1 763 620 1083, aoliv119@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Early Onset Primary Adverse Events (PAEs) (time frame: Up to 7 days post-procedure). 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?
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 Nov 2026.