FARAPULSE Workflow Assessment Registry

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 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: • Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.

Trial locations and contacts

28 sites in 10 countries.

About this study

Conditions

Atrial Fibrillation (AF)

Keywords

Catheter Ablation, Pulsed Field Ablation, FARAPULSE, Workflow Assessment

Medical subject headings

Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Association of patient demographics with Index procedure Workflow-related variables

   Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management

   Measured: Index Procedure

2. Association of safety parameters with Index procedure Workflow-related variables

   Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management

   Measured: 12 months

3. Association of effectiveness parameters with Index procedure Workflow-related variables

   Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management

   Measured: 12 months

4. Association of patient demographics with effectiveness parameters

   Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters

   Measured: 12 months

5. Association of patient demographics with safety parameters

   Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula)

   Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Oct 2024
2. Study start6 May 2025
3. Primary completion15 Feb 2027 (estimated)
4. Study completion15 Feb 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
• More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
• 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.