NL-OMON45547
Completed
Not Applicable
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation with Focal Impulse and Rotor Modulation Guided Procedures (Redo-FIRM) - Redo-FIRM
Abbott Electrophysiology0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Abbott Electrophysiology
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female 18 \- 80 years of age.
- •2\. Has at least one (1\) episode of spontaneous persistent or paroxysmal atrial fibrillation documented by rhythm strip/ ECG following the most recent ablation.
- •3\. Had one (1\) previous AF ablation after 01 January 2013, but NOT within the last 3 months. Detailed documentation of the previous ablation strategy is required.
- •4\. Oral anticoagulation required with either Novel Oral Anticoagulant (NOAC) or Warfarin (in the case of Warfarin, therapeutic INR \>\= 2\.0 for at least three weeks prior to randomization) for those subjects who meet two or more of the following criteria:
- •a. Age 65 years or older
- •b. Diabetes
- •c. Coronary artery disease (CAD)
- •d. Congestive heart failure
- •e. Hypertension with systolic\>165 mm Hg
- •5\. Willingness and able to remain on anti\-coagulation therapy for a minimum of 3 months post procedure for all subjects and at least 12 months post procedure if the patient is on anti\-coagulation pre\-procedure or has CHADS2 score \>\= 2 (or CHADs\-Vasc score \>1\).
Exclusion Criteria
- •1\. Presence of structural heart disease of clinical significance including:
- •a. Coronary artery disease with either:
- •o Coronary artery bypass surgery (CABG) within the last six months, or
- •o Stable/unstable angina or ongoing myocardial ischemia
- •b. Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation.
- •2\. NYHA Class IV.
- •3\. Ejection fraction \< 35% (within previous 6 months).
- •4\. Previous AF ablation within the last 3 months.
- •5\. ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
- •6\. History of myocardial infarction (MI) within the past three (3\) months.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Randomised trial on the efficacy of Ablation vs no Ablation of Barrett's oesophagus with Argon Plasma Coagulation following laparoscopic fundoplication for the reversal of Barrett's oesophagusBarrett's oesophagusOther - Oesophageal (gullet)ACTRN12607000292471Department of Surgery, Flinders University65
Completed
Not Applicable
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided ProceduresPersistent Atrial FibrillationParoxysmal Atrial FibrillationNCT02799043Abbott Medical Devices269
Active, not recruiting
Not Applicable
Randomised trial of Ablation vs no Ablation of Barrett's oesophagus with Argon Plasma Coagulation in patients who have not undergone surgery for refluxBarrett's oesophagusOther - Oesophageal (gullet)ACTRN12607000293460Dept of Surgery, Flinders University100
Recruiting
Not Applicable
Evaluation of ablation in the treatment of arrhythmiaSupraventricular tachyarrythmia.Supraventricular tachycardiaI47.1IRCT20160926029976N5Vice Chancellor For Research, Babol University Of Medical Sciences80
Active, not recruiting
Phase 4
The Randomized Controlled Trial Evaluating Utility of Catheter Ablation Us ing ExTRa mapping for Atrial FibrillatioAtrial fibrillationD001281JPRN-jRCT1052210026Shizuta Satoshi80