Feasibility trial of a staged epicardial and endocardial approach for treatment of patients with persistent or long standing persistent atrial fibrillation with radiofrequency ablation

Feasibility trial of a staged epicardial and endocardial approach for treatment of patients with persistent or long standing persistent atrial fibrillation with radiofrequency ablation - Staged DEEP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37310

Enrollment

Registered

2012-12-19

Start date

2013-05-23

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation fibrillation

Interventions

Minimally invasive thoracoscopic pulmonary vein ablation, followed by catheter ablation within 1-10 days after the first procedure.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with symptomathic persistent or long standing persistent atrial fibrillation refractory to a minimum of one anti-arrhythmic drug, more than 18 years of age.

Exclusion criteria

Exclusion criteria: Previous cardiothoracic surgery NYHA class IV heart failure or left ventricle ejection fraction

Design outcomes

Secondary

Measure	Time frame
Efficacy: - Acute Procedure Success: defined as patient meeting all of the following criteria upon completion of the index-EP procedure: a. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); b. Bi-directional cavotricuspid isthmus block; c. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); d. SVC isolation, if encircling SVC lesion performed. - Assessment of AF Free status at 6 or 12 month follow-up a. With or without AAD b. AF free through 12 month assessment based on Kaplan Meier analysis - Incidence of Reintervention to address Atrial Dysrhythmia through 12 month follow-up assessment. - Incidence of DC cardioversion to address Atrial Dysrhythmia through 12 month follow-up assessment. - Improvement in AF Symptom Checklist Frequency and Severity Scores. Safety: Overall Serious Event Rate reported through the 12 month follow-up assessment, as adjudicated by Independent Physician Adjudicator based on attribution: a. AtriCure Bipolar System Investigational Device b. Epicardial Surgical Procedure Related Adverse Event Rate c. Endocardial EP Procedure Related Adverse Event Rate d. Other (e.g. comorbid conditions)	—

Measure

Time frame

Efficacy: - Acute Procedure Success: defined as patient meeting all of the following criteria upon completion of the index-EP procedure: a. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); b. Bi-directional cavotricuspid isthmus block; c. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); d. SVC isolation, if encircling SVC lesion performed. - Assessment of AF Free status at 6 or 12 month follow-up a. With or without AAD b. AF free through 12 month assessment based on Kaplan Meier analysis - Incidence of Reintervention to address Atrial Dysrhythmia through 12 month follow-up assessment. - Incidence of DC cardioversion to address Atrial Dysrhythmia through 12 month follow-up assessment. - Improvement in AF Symptom Checklist Frequency and Severity Scores. Safety: Overall Serious Event Rate reported through the 12 month follow-up assessment, as adjudicated by Independent Physician Adjudicator based on attribution: a. AtriCure Bipolar System Investigational Device b. Epicardial Surgical Procedure Related Adverse Event Rate c. Endocardial EP Procedure Related Adverse Event Rate d. Other (e.g. comorbid conditions)

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Primary

Measure	Time frame
Efficacy: Absence of atrial fibrillation at 12 month follow up assesment based on 14-day ECG monitoring. Safety: Serious adverse events that are attributed to any of the following: (a) AtriCure Bipolar System investigational devices; or (b) epicardial surgical procedure; or (c) endocardial EP procedure These events must occur in the first 30 days post-index EP procedure or hospital discharge, whichever is longer (unless otherwise noted),	—

Measure

Time frame

Efficacy: Absence of atrial fibrillation at 12 month follow up assesment based on 14-day ECG monitoring. Safety: Serious adverse events that are attributed to any of the following: (a) AtriCure Bipolar System investigational devices; or (b) epicardial surgical procedure; or (c) endocardial EP procedure These events must occur in the first 30 days post-index EP procedure or hospital discharge, whichever is longer (unless otherwise noted),

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)