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New treatment option for Persistent Atrial Fibrillation
Official title Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
ClinicalTrials.gov ID: NCT06735534
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age, or older if required by local law
- Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
- Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
- Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm...
- If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index...
You likely can't join if
- Atrial exclusions - Any of the following atrial conditions: a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available...
- 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...
- Presence of any of the following:
See the full eligibility criteria
Who can join
- ≥ 18 years of age, or older if required by local law
- Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
- Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
- Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device. OR
- If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
- Willing and capable of providing informed consent
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
What rules you out
- 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...
- 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...
- 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+)
- Moderate to severe aortic stenosis
- 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:
- Heart failure associated with NYHA Class III or IV
- Documented LVEF \< 40% as documented within the previous 12 months
- Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
- Body Mass Index (BMI) \>45.0
- CHA2DS2-VASc score ≥5
- Any of the following events within 90 Days of the Consent Date:
- Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease
- Cardiac surgery: Any cardiac surgery
- Heart failure hospitalization: Heart failure hospitalization
- Pericardium: Pericarditis or symptomatic pericardial effusion
- GI bleeding: Gastrointestinal bleeding
- Neurovascular event: Stroke, TIA, or intracranial bleeding
- Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
- Carotid intervention: Carotid stenting or endarterectomy
- Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0%
- Any of the following congenital conditions:
- Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- Methemoglobinemia: History of known congenital methemoglobinemia
- G6PD deficiency: History of known G6PD deficiency
- Any of the following conditions:
- Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis. Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Jonesboro, Arkansas, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- Stanford, California, United States
- Littleton, Colorado, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Savannah, Georgia, United States
- Boise, Idaho, United States
- Oak Lawn, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Fall River, Massachusetts, United States
- Royal Oak, Michigan, United States
- Lebanon, New Hampshire, United States
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Jonesboro, Arkansas, United States; Los Angeles, California, United States; Oxnard, California, United States; Stanford, California, United States; Littleton, Colorado, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.