Home › Trials › NCT06735534

Repeat pulsed-field ablation for persistent atrial fibrillation including mitral isthmus ablation

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

Not applicable Interventional Boston Scientific Corporation · NCT06735534

This trial will test whether the FARAPULSE pulsed field ablation system can safely and effectively re-treat adults with persistent atrial fibrillation who had one prior ablation and now have symptomatic recurrence.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment376 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Locations39 sites (Mobile, Alabama and 38 other locations)
Trial IDNCT06735534 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label, multi-center study using the FARAWAVE and FARAPOINT pulsed field ablation catheters to perform re-ablation, including mitral isthmus and pulmonary vein isolation as needed. Eligible participants are adults with a single prior endocardial AF ablation that included pulmonary vein isolation and documented symptomatic persistent AF recurrence at least 60 days after the index procedure. The study will collect safety and effectiveness data following the repeat PFA procedure and monitor rhythm outcomes with standard follow-up testing. Procedures and follow-up occur at participating investigational centers in the United States.

Who should consider this trial

Good fit: Adults who had one previous endocardial AF ablation that included pulmonary vein isolation and who now have documented symptomatic persistent AF recurrence at least 60 days after that procedure are ideal candidates.

Not a fit: People with more than one prior AF ablation, active contraindications to catheter ablation, or inability to attend a participating center are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer people with recurrent persistent AF a more targeted re-ablation option that may reduce collateral tissue injury and improve rhythm control.

How similar studies have performed: Pulsed field ablation has shown promising safety and efficacy for initial pulmonary vein isolation in earlier trials, but applying it for repeat treatment of persistent AF and mitral isthmus ablation is relatively new.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

1. 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
2. Cardiovascular exclusions - Any of the following CV conditions:

   1. History of sustained ventricular tachycardia or any ventricular fibrillation
   2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
   3. 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
   4. 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
   5. Hypertrophic cardiomyopathy
   6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
   7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
   8. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
3. Any of the following conditions at baseline:

   1. Heart failure associated with NYHA Class III or IV
   2. Documented LVEF \< 40% as documented within the previous 12 months
   3. 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
   4. Body Mass Index (BMI) \>45.0
   5. CHA2DS2-VASc score ≥5
4. Any of the following events within 90 Days of the Consent Date:

   1. 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
   2. Cardiac surgery: Any cardiac surgery
   3. Heart failure hospitalization: Heart failure hospitalization
   4. Pericardium: Pericarditis or symptomatic pericardial effusion
   5. GI bleeding: Gastrointestinal bleeding
   6. Neurovascular event: Stroke, TIA, or intracranial bleeding
   7. Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
   8. Carotid intervention: Carotid stenting or endarterectomy
   9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0%
5. Any of the following congenital conditions:

   1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
   2. Methemoglobinemia: History of known congenital methemoglobinemia
   3. G6PD deficiency: History of known G6PD deficiency
6. Any of the following conditions:

   1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
   2. 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 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

Where this trial is running

Mobile, Alabama and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Persistent Atrial FibrillationPulsed Field Ablation)Pulmonary Vein IsolationRecurrent Arrhythmiacavo-tricuspid isthmusCTI dependent flutterAnti Arrhythmic DrugsAtrial Flutter
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.