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The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVEâ„¢ and FARAPOINTâ„¢ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Prospective | Other | Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSEâ„¢ Pulsed Field Ablation System | Device | The FARAPULSEâ„¢ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation. The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy. The FARAPOINTâ„¢ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety endpoint rate | The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure. | 60 days |
| The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success. | The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success). | 24 hours |
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Inclusion Criteria:
OR
Exclusion Criteria:
Atrial exclusions - Any of the following atrial conditions:
a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus
Cardiovascular exclusions - Any of the following CV conditions:
History of sustained ventricular tachycardia or any ventricular fibrillation
AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.
Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment
Presence of any of the following:
• Any prosthetic heart valve, ring or repair
• Moderate to severe mitral valve stenosis
• More than moderate mitral regurgitation (>3+)
Hypertrophic cardiomyopathy
Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
Any of the following conditions at baseline:
Any of the following events within 90 Days of the Consent Date:
Any of the following congenital conditions:
Any of the following conditions:
Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
l. Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period m. General health conditions: Health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility.
p. Life expectancy: Predicted life expectancy less than one (1) year
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Mathson | Contact | 612.417.9538 | Kristin.Mathson@bsci.com | |
| Kaitlyn Aldrich | Contact | +16515824790 | kaitlyn.aldrich@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Moussa Mansour,, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Recruiting | Mobile | Alabama | 36607 | United States |
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| Arrhythmia Research Group-Research Facility | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| University of Southern California Hospital | Recruiting | Los Angeles | California | 90033 | United States |
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| St. John's Regional Medical Center | Recruiting | Oxnard | California | 93030 | United States |
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| Stanford University Medical Center | Recruiting | Stanford | California | 94305 | United States |
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| South Denver Cardiology Associates, PC | Recruiting | Littleton | Colorado | 80120 | United States |
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| HCA Florida Mercy Hospital | Recruiting | Miami | Florida | 33133 | United States |
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| Naples Comprehensive Health | Recruiting | Naples | Florida | 34102 | United States |
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| AdventHealth Orlando-Hospital | Recruiting | Orlando | Florida | 32803 | United States |
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| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
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| AdventHealth Tampa-Hospital | Recruiting | Tampa | Florida | 33613 | United States |
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| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Atrium Health Navicent The Medical Center | Recruiting | Macon | Georgia | 32201 | United States |
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| Memorial Health University Medical Center | Recruiting | Savannah | Georgia | 31404 | United States |
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| St. Luke's Boise Medical Center | Recruiting | Boise | Idaho | 83712 | United States |
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| Advocate Christ Medical Center-Hospital | Recruiting | Oak Lawn | Illinois | 60453 | United States |
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| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Southcoast Physicians Group | Recruiting | Fall River | Massachusetts | 02720 | United States |
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| William Beaumont Hospital-Hospital | Recruiting | Royal Oak | Michigan | 48073 | United States |
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| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Virtua Health Inc. | Recruiting | Marlton | New Jersey | 08053 | United States |
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| Lovelace Medical Center | Recruiting | Albuquerque | New Mexico | 87102 | United States |
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| Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
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| Weill Cornell Medical University | Recruiting | New York | New York | 10065 | United States |
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| Bethesda North Hospital | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Oklahoma Heart Institute | Recruiting | Tulsa | Oklahoma | 74104 | United States |
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| Trident Medical Center | Recruiting | Charleston | South Carolina | 29406 | United States |
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| Texas Cardiac Arrhythmia Research | Recruiting | Austin | Texas | 78705 | United States |
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| Christus Trinity Mother Frances Health System | Recruiting | Tyler | Texas | 75701 | United States |
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| St. Mark's Hospital | Recruiting | Salt Lake City | Utah | 84124 | United States |
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| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| John Hunter Hospital | Recruiting | New Lambton Heights | New South Wales | 606-8507 | Australia |
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| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| St. Andrew's War Memorial Hospital | Recruiting | Brisbane | Queensland | 4001 | Australia |
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| Victorian Heart Hospital | Recruiting | Clayton | Victoria | 3168 | Australia |
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| The Royal Melbourne Hospital | Recruiting | Parkville | Victoria | 3050 | Australia |
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| The Alfred Hospital | Recruiting | Melbourne | Australia |
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| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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