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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01695824
Enrollment
96
Registered
2012-09-28
Start date
2011-12-31
Completion date
2014-11-30
Last updated
2015-07-08

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

Conditions

Atrial Fibrillation

Keywords

catheter ablation

Brief summary

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

Interventions

DEVICELAA 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.

PROCEDURERFA 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.

DRUGWarfarin

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.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frame
All stroke12 months
Systemic embolism12 months
Cardiovascular death12 months

Secondary

MeasureTime frame
Technical success45 days
Left atrial appendage (LAA) coverage45 days
Procedure success45 days
30 day major adverse event (MAE)30 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026