20 and older, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Safety Event-free at 12 Months Post ProcedurePrimary· 12 months
This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below).
Acute primary safety endpoint events are defined as the following:
* Death
* Myocardial infarction (MI)
* Vagal Nerve Injury/Gastroparesis
* Transient ischemic attack (TIA)
* Stroke/Cerebrovascular accident (CVA)
* Thromboembolism
* Pericarditis
Group
Value
95% CI
Treatment With Ablation Catheter
368
Number of Participants Effectiveness Event -Free at 12 Months Post ProcedurePrimary· 12 Months
The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure.
Primary effectiveness events are defined as:
* Acute procedural failure
* More than one repeat procedure during the blanking period (90 days post index procedure)
* Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure
* Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial
Group
Value
95% CI
Treatment With Ablation Catheter
218
Number of Participants Event Free Rate (Secondary)Secondary· 12 Months
The secondary effectiveness endpoint is defined as the event-free at 12 months post-procedure.
Secondary effectiveness events are defined as:
* Acute procedural failure
* More than one repeat procedure during the blanking period (90 days post index procedure)
* Documented symptomatic atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure
* Any of the following interventions for atrial fibrillation, or new onset of atrial flutte
Group
Value
95% CI
Treatment With Ablation Catheter
102
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment With Ablation Catheter
Serious: 135/383 (35%)
Deaths: 5/383
Serious adverse events (79 terms)
Reaction
System
Treatment With Ablation Ca…
Atrial Fibrillation
Cardiac disorders
—
Atrial Flutter
Cardiac disorders
—
Gastrointestinal
Gastrointestinal disorders
—
Pulmonary
Respiratory, thoracic and mediastinal disorders
—
Angina/Chest pain
Surgical and medical procedures
—
Physical trauma
General disorders
—
Abnormal laboratory values
General disorders
—
Chest pain - Other
General disorders
—
Pericardial effusion - EP procedure
Injury, poisoning and procedural complications
—
Musculoskeletal
Musculoskeletal and connective tissue disorders
—
Neurological
Nervous system disorders
—
Myocardial infarction
Vascular disorders
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 21 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03729830.