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Treatment of PAF With the Synaptic System (Sensation)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synaptic Cryoablation System
Sponsored by
Synaptic Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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: 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cryoablation Balloon

    Arm Description

    The Synaptic Cryo Balloon will be used to isolate all targeted pulmonary veins.

    Outcomes

    Primary Outcome Measures

    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 following major complications as defined in the 2017 HRS expert consensus statement
    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.

    Secondary Outcome Measures

    Safety - Change from baseline NIH Stroke Scale post-ablation
    Change from baseline NIH Stroke Scale post-ablation
    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)
    Safety - Incidence of late onset (>7 days) of SAEs
    Incidence of late onset (>7 days) of SAEs
    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
    Effectiveness - Rate of pulmonary vein isolation on a per-vein basis
    • Rate of pulmonary vein isolation on a per-vein basis
    Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
    Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
    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
    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
    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
    Performance - 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
    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
    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
    Performance - Total cryoablation time for index procedure
    Total cryoablation time for index procedure
    Performance - Total fluoroscopy time for index procedure
    Total fluoroscopy time for index procedure
    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
    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

    Full Information

    First Posted
    May 26, 2023
    Last Updated
    June 26, 2023
    Sponsor
    Synaptic Medical Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05905835
    Brief Title
    Treatment of PAF With the Synaptic System
    Acronym
    Sensation
    Official Title
    Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Synaptic Medical Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paroxysmal Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    185 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cryoablation Balloon
    Arm Type
    Experimental
    Arm Description
    The Synaptic Cryo Balloon will be used to isolate all targeted pulmonary veins.
    Intervention Type
    Device
    Intervention Name(s)
    Synaptic Cryoablation System
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs)
    Description
    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 following major complications as defined in the 2017 HRS expert consensus statement
    Time Frame
    6 months
    Title
    Effectiveness
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Safety - Change from baseline NIH Stroke Scale post-ablation
    Description
    Change from baseline NIH Stroke Scale post-ablation
    Time Frame
    Day 1
    Title
    Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
    Description
    Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
    Time Frame
    7 days
    Title
    Safety - Incidence of late onset (>7 days) of SAEs
    Description
    Incidence of late onset (>7 days) of SAEs
    Time Frame
    12 months
    Title
    Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
    Description
    Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
    Time Frame
    Day 0
    Title
    Effectiveness - Rate of pulmonary vein isolation on a per-vein basis
    Description
    • Rate of pulmonary vein isolation on a per-vein basis
    Time Frame
    Day 0
    Title
    Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
    Description
    Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
    Time Frame
    12 months
    Title
    Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
    Description
    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
    Title
    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
    Description
    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
    Title
    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
    Description
    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
    6 months
    Title
    Performance - 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
    Description
    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
    Day 0
    Title
    Performance - Procedure time, defined as the time elapsed from first venous access to last sheath removal
    Description
    Procedure time, defined as the time elapsed from first venous access to last sheath removal
    Time Frame
    Day 0
    Title
    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
    Description
    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
    Title
    Performance - Total cryoablation time for index procedure
    Description
    Total cryoablation time for index procedure
    Time Frame
    Day 0
    Title
    Performance - Total fluoroscopy time for index procedure
    Description
    Total fluoroscopy time for index procedure
    Time Frame
    Day 0
    Title
    Performance - Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
    Description
    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
    Title
    Performance -Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
    Description
    Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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: 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of PAF With the Synaptic System

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