N/A
N=24
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Persistent Atrial Fibrillation · Longstanding Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01246466 ↗Enrolled (actual)
24
Serious AEs
66.7%
Results posted
Apr 2021
Primary outcome: Primary: Primary Safety Endpoint — 0; 0; 4.2; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hybrid: AtriCure Bipolar System & EP ablation procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
0; 0; 4.2; 0; 4.2; 0 | — |
| PRIMARY Absence of Atrial Fibrillation |
22; 20; 19; 15 | — |
| SECONDARY Overall Serious Device or Procedure Related Adverse Event Rate |
0; 1; 0; 1; 0; 0 | — |
| SECONDARY Acute Procedure Success |
100; 100; 100; 95.8; 100.0; 100.0 | — |
| SECONDARY Absence of Atrial Fibrillation |
22; 20; 19; 15 | — |
| SECONDARY Number of Participants With Reintervention to Address Atrial Dysrhythmia |
2 | — |
| SECONDARY Number of Participants With DC Cardioversion |
— | — |
| SECONDARY Improvement in AF |
13.4; 9.8 | — |
| SECONDARY Duration of Procedure |
8.9; 3.9; 2.9 | — |
Summary
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
- Patient is willing and able to provide written informed consent.
- Patient has a life expectancy of at least 2 years.
- Patient is willing and able to attend the scheduled follow-up visits.
Exclusion Criteria
- Prior Cardiothoracic Surgery.
- Patient has NYHA Class IV heart failure.
- Evidence of underlying structural heart disease requiring surgical treatment.
- Ejection fraction 6.0 cm
- Renal Failure
- Stroke within previous 6 months.
- Known carotid artery stenosis greater than 80%.
- Evidence of significant active infection or endocarditis.
- Pregnant woman or women desiring to become pregnant in the next 24 months.
- Presence of thrombus in the left atrium determined by echocardiography.
- History of blood dyscrasia.
- Contraindication to anticoagulation, based on Investigator's opinion.
- Mural thrombus or tumor.
- Moderate to Severe COPD
Data sourced from ClinicalTrials.gov (NCT01246466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.