Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695824
• Other study ID #: WA-PR-AF
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2012
• Last updated: July 7, 2015
• Start date: December 2011
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)

• Eligible for long term warfarin

• CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])

Exclusion Criteria:

• Contraindicated for warfarin

• Contraindicated for aspirin or clopidogrel (Plavix)

• CHF Class 4

• Implanted mechanical valve

• Atrial septal or Patent Foramen Ovale (PFO) device

• Platelets < 100,000 or hemoglobin < 10

• Left ventricular ejection fraction (LVEF) < 30%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• LAA occluder
The procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release.

Procedure:
• RFA ablation
The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43?C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43?C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.

Drug:
• Warfarin
Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for "Watchman group" All patients in "Warfarin group" continued to receive Warfarin during hole study period with IMR from II to III.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All stroke		12 months	Yes
Primary	Systemic embolism		12 months	No
Primary	Cardiovascular death		12 months	No
Secondary	Technical success		45 days	No
Secondary	Procedure success		45 days	No
Secondary	30 day major adverse event (MAE)		30 days	Yes
Secondary	Left atrial appendage (LAA) coverage		45 days	No

External Links

•   State Research Institute of Circulation Pathology Official Site