Paroxysmal Atrial FibrillationSensationNCT05905835
Treatment of PAF With the Synaptic System
A study testing Synaptic Cryoablation System in people with Paroxysmal Atrial Fibrillation, run by Synaptic Medical Corporation at 10 sites in United States.
Trial summary
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure. 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?
- Synaptic Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Sep 2023to 5 Dec 2025
- 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
- Diagnosis of symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either through procedure or drug therapy) within seven (7) days of onset. Minimum documentation includes the following:
- A physician's note indicating recurrent atrial fibrillation (AF) which includes at least two (2) symptomatic AF episodes within six (6) months prior to enrollment; AND
- One electrocardiographically (from any form of rhythm monitoring, including consumer devices) documented AF episode within 12 months prior to enrollment.
- Refractory or intolerant to at least one (1) Class I or III anti-arrhythmic medication or contraindicated to any class I or III medication.
- Suitable candidate for catheter ablation.
- Adults aged 18 - 80 years.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
- Willing and able to provide informed consent.
Who cannot join
- Diagnosis of persistent AF, i.e., continuous AF lasting longer than seven (7) days from onset
- In the opinion of the Investigator, any known contraindication to an atrial ablation or anticoagulation. Including but not limited to the identification of any atrial thrombus or evidence of sepsis
- History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Body Mass Index (BMI) ≥ 40
- Structural heart disease or implanted devices as described below:
Show all 28Show fewer
- Left ventricular ejection fraction (LVEF) < 40% based on most recent transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) performed ≤ 180 days prior to enrollment
- Left atrial diameter > 5.5 cm or left atrial volume > 50 ml/m2 indexed based on most recent TTE or TEE performed ≤ 180 days prior to enrollment
- Implanted pacemaker, ICD, CRT device within 90 days prior to enrollment
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
- Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
- Presence of a left atrial appendage occlusion device
- Presence of any pulmonary vein stents
- Coronary artery bypass graft (CABG), PTCA, PCI, or coronary stent procedures within 90 days prior to enrollment
- Unstable angina or ongoing myocardial ischemia
- ST-Elevation Myocardial Infarction (STEMI) within 90 days prior to enrollment
- Moderate or Severe Mitral Insufficiency or Mitral Stenosis, severity based on the most recent TTE or TEE performed ≤ 180 days prior to enrollment
- Evidence of left atrial thrombus
- History of cryoglobulinemia
- Significant untreated restrictive or obstructive pulmonary disease or chronic respiratory condition
- Renal failure requiring dialysis
- History of blood clotting or bleeding disease
- History of documented cerebral infarct, TIA or systemic embolism,excluding post-operative deep vein thrombosis (DVT) ≤ 180 days prior to enrollment
- Active systemic infection
- Pregnant or lactating (current or anticipated during the study)
- Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
- Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes, but not limited to, vulnerable patient population, mental illness, Gastroesophageal Reflux Disease (GERD), addictive disease, terminal illness with a life expectancy of less than two (2) years, or extensive travel away from the research center)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, 72401
St. Luke's Mid America
Kansas City, Missouri, 64111
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Northwell Health - Lenox Hill Hospital
New York, New York, 10075
Banner University Medical Center
Phoenix, Arizona, 85006
Dignity Health Arizona Research Enterprise
Phoenix, Arizona, 85006
VCU Pauley Heart Center
Richmond, Virginia, 23298
Mercy General Hospital
Sacramento, California, 95819
Christus Health Frances Hospital
Tyler, Texas, 75701
About this study
Official title: Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.
Read the detailed description
A multi-center, open-label, prospective, single-arm, pre-market clinical study. Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions (TTM) after the 3-month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Synaptic Cryoablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synaptic Cryoablation SystemDevice
The Synaptic Cryo Balloon must be used to isolate all targeted pulmonary veins. Entrance block will be confirmed in all targeted pulmonary veins (PVs) after a 20-minute waiting period or provocative testing with adenosine or isoproterenol. Any additional ablation in the LA beside PV isolation is not allowed in this protocol. Additional ablation of the cavo-tricuspid isthmus (CTI) with a conventional market-approved RF catheter is allowed only in case a typical atrial flutter is documented in prior patient history or occurs during the case (either spontaneously or inducible).
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation Balloon | Experimental | The Synaptic Cryo Balloon will be used to isolate all targeted pulmonary veins. Receives: Device: Synaptic Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs)
The primary endpoint for safety is an analysis of the proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs) that occur during the procedure or through the 6-month follow-up of the study. MAEs include any of the major complications as defined in the 2017 HRS expert consensus statement
Measured: 6 months
Effectiveness
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90- day blanking period.
Measured: 12 months
Secondary outcomes (16)
Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
Measured: 7 days
Safety - Incidence of late onset (>7 days) of SAEs
Incidence of late onset (>7 days) of SAEs
Measured: 12 months
Safety - Change from baseline NIH Stroke Scale post-ablation
Change from baseline NIH Stroke Scale post-ablation
Measured: Day 1
Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
Measured: Day 0
Effectiveness - Rate of pulmonary vein isolation on a per-vein basis
- Rate of pulmonary vein isolation on a per-vein basis
Measured: Day 0
Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
Measured: 12 months
Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
Measured: 12 months
Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
Measured: 12 months
Effectiveness - Failure-free rate as defined in primary effectiveness endpoint at 6 months post procedure
Failure-free rate as defined in primary effectiveness endpoint at 6 months post procedure
Measured: 6 months
Performance - Single procedure success defined as freedom from primary effectiveness failure without a repeat procedure
Single procedure success defined as freedom from primary effectiveness failure without a repeat procedure
Measured: 12 months
Performance - Procedure time, defined as the time elapsed from first venous access to last sheath removal
Procedure time, defined as the time elapsed from first venous access to last sheath removal
Measured: Day 0
Performance - Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI
Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI
Measured: Day 0
Performance - Total cryoablation time for index procedure
Total cryoablation time for index procedure
Measured: Day 0
Performance - Total fluoroscopy time for index procedure
Total fluoroscopy time for index procedure
Measured: Day 0
Performance - Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
Measured: Day 0
Performance -Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start20 Sep 2023
- Primary completion5 Nov 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synaptic Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905835
- Sponsor's protocol ID
- CS-0001
- Acronym
- Sensation
- Status last verified
- Sep 2025
- First submitted
- 26 May 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
- ClinicalTrials.gov ID
- NCT05905835
- Acronym / sponsor ID
- Sensation / CS-0001
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Synaptic Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 15 Jun 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.
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.
Detailed description
A multi-center, open-label, prospective, single-arm, pre-market clinical study. Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions (TTM) after the 3-month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation Balloon | Experimental | Device: Synaptic Cryoablation SystemThe Synaptic Cryo Balloon will be used to isolate all targeted pulmonary veins. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either through procedure or drug therapy) within seven (7) days of onset. Minimum documentation includes the following:
- Refractory or intolerant to at least one (1) Class I or III anti-arrhythmic medication or contraindicated to any class I or III medication.
- Suitable candidate for catheter ablation.
- Adults aged 18 - 80 years.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Key exclusion criteria (28 listed)
- Diagnosis of persistent AF, i.e., continuous AF lasting longer than seven (7) days from onset
- In the opinion of the Investigator, any known contraindication to an atrial ablation or anticoagulation. Including but not limited to the identification of any atrial thrombus or evidence of sepsis
- History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Body Mass Index (BMI) ≥ 40
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 |
|---|---|---|
| Synaptic Cryoablation SystemThe Synaptic Cryo Balloon must be used to isolate all targeted pulmonary veins. Entrance block will be confirmed in all targeted pulmonary veins (PVs) after a 20-minute waiting period or provocative testing with adenosine or isoproterenol. Any additional ablation in the LA beside PV isolation is not allowed in this protocol. Additional ablation of the cavo-tricuspid isthmus (CTI) with a conventional market-approved RF catheter is allowed only in case a typical atrial flutter is documented in prior patient history or occurs during the case (either spontaneously or inducible). | Device | Cryoablation Balloon |
Primary outcome
safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs)
Time frame: 6 months
The primary endpoint for safety is an analysis of the proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs) that occur during the procedure or through the 6-month follow-up of the study. MAEs include any of the major complications as defined in the 2017 HRS expert consensus statement
Effectiveness
Time frame: 12 months
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90- day blanking period.
16 secondary outcomes
Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
Time frame: 7 days
Safety - Incidence of late onset (>7 days) of SAEs
Time frame: 12 months
Safety - Change from baseline NIH Stroke Scale post-ablation
Time frame: Day 1
Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
Time frame: Day 0
Effectiveness - Rate of pulmonary vein isolation on a per-vein basis
Time frame: Day 0
Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
Time frame: 12 months
Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
Time frame: 12 months
Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
Time frame: 12 months
Effectiveness - Failure-free rate as defined in primary effectiveness endpoint at 6 months post procedure
Time frame: 6 months
Performance - Single procedure success defined as freedom from primary effectiveness failure without a repeat procedure
Time frame: 12 months
Performance - Procedure time, defined as the time elapsed from first venous access to last sheath removal
Time frame: Day 0
Performance - Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI
Time frame: Day 0
Performance - Total cryoablation time for index procedure
Time frame: Day 0
Performance - Total fluoroscopy time for index procedure
Time frame: Day 0
Performance - Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
Time frame: Day 0
Performance -Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
Time frame: 12 months
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 11 Sep 2025.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synaptic Cryoablation System in people with Paroxysmal Atrial Fibrillation, run by Synaptic Medical Corporation at 10 sites in United States.
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 8 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
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?
safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs) (time frame: 6 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?
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 11 Sep 2025.