Necessity of Anti-Arrhythmic Medication After Surgical Ab... | NCT01416935

NCT01416935

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Amiodarone	Active Comparator	Patient will be randomized not to receive to Amiodarone post Cox-Maze procedure unless indicated.	Other: No Amiodarone
Amiodarone	No Intervention	Patients randomized to receive Amiodarone post Cox-Maze procedure which is our current standard of care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Amiodarone	Other	This is a randomized study whereby patients who would routinely/usually be scheduled to receive Amiodarone as their anti-arrhythmic medication post surgical ablation will be randomly assigned to receive Amiodarone or no Amiodarone, but all other medications would remain as prescribed for patients following surgical ablation which will include beta blockade therapy unless contraindicated which is an American Heart Associated and Heart Rhythm Society recognized treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation	To demonstrate equality in clinically significant recurrence of AF following ablation while showing superiority for complication and side effect rates in those off Amiodarone vs. those on. •% recurrence AF by telemetry at 3 wks and 24-48 hr Holter monitoring at 6 and 12 wks post procedure, EKG at first visit between 6 and 12 wks post discharge and or ER visit for rapid heart rate in atrial arrhythmia requiring treatment; permanent pacemaker interrogation reports at first follow up visit. •Post-procedure major adverse event rate at 6 mos post-procedure related to side effects of Amiodarone.	3, 6, 12 weeks and 6 months post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Event Rate	To characterize the composite post-procedure major adverse event rate (pericardial/ pleural effusion with elevated INR, hemorrhagic stroke with elevated INR, thromboembolic stroke) within 30 days post-procedure or prior to hospital discharge whatever comes last	30 days post-procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is ≥ 18 years of age
Subject must be diagnosed with Persistent and/or Longstanding Persistent Atrial fibrillation as classified by the HRS Guidelines 8 [0]
Subject must be selected as a candidate to undergo the Cox- Maze procedure for ablation of atrial fibrillation
The Cox Maze procedure may be done as a stand alone procedure or combined with other cardiac surgical procedures either via a median sternotomy or a right thoracotomy:
Subject has a Left Ventricular Ejection Fraction (LVEF) ≥ 30%
Subject would normally be prescribed Amiodarone as an anti arrhythmic medication post surgical ablation
Subject is able and willing to provide written informed consent and HIPAA authorization
Subject is able and willing to comply with all study requirements including attending all follow-up visits as deemed necessary by personal physician (cardiologist)
Subject has a life expectancy of at least one year

Exclusion Criteria:

Subject has undergone previous attempts at surgical Maze procedure or other AF operation, including surgical or catheter ablation Subject has an accessory pathways disorder (e.g. Wolff-Parkinson-White syndrome)
Subject is in Class IV NYHA
Subject has had a documented MI within 6 weeks prior to study enrollment
Subject needs emergent cardiac surgery (i.e. cardiogenic shock)
Subject has known carotid artery stenosis greater than 80%
Subject has a current diagnosis of active systemic infection
Subject is pregnant, planning to become pregnant within 12-14 months, or lactating
Subject requires preoperative intra-aortic balloon pump or intravenous inotropes
Subject has renal failure requiring dialysis
Subject is diagnosed with hepatic failure
Subject is on anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Subject has a known connective tissue disorder
Subject is incarcerated
Subject has previous or current therapy that could compromise tissue integrity including thoracic radiation, chemotherapy, long-term oral or injected steroids
Subject is an intravenous drug and/or alcohol abuser
Subject is participating in concomitant research studies of investigational products ( e.g. Appendage closure devices, atrial septal defect patches)