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

NCT01695824 | Completed Phase 2 DMC

• 1 other identifier: WA-PR-AF
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

catheter ablation

Outcome Measures

Primary Outcomes (3)

• All stroke

  12 months

• Systemic embolism

  12 months

• Cardiovascular death

  12 months

Secondary Outcomes (4)

• Technical success

  45 days

• Procedure success

  45 days

• 30 day major adverse event (MAE)

  30 days

• Left atrial appendage (LAA) coverage

  45 days

Study Arms (2)

LAA occluder

ACTIVE COMPARATOR

Device: LAA occluder; Procedure: RFA ablation; Drug: Warfarin

Warfarin

ACTIVE COMPARATOR

Procedure: RFA ablation; Drug: Warfarin

Interventions

LAA occluder DEVICE

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.

Also known as: Watchman

LAA occluder

RFA ablation PROCEDURE

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.

LAA occluder; Warfarin

Warfarin DRUG

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.

LAA occluder; Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[TIA\])

You may not qualify if:

• 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%

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (1)

• Romanov A, Pokushalov E, Artemenko S, Yakubov A, Stenin I, Kretov E, Krestianinov O, Grazhdankin I, Risteski D, Karaskov A, Steinberg JS. Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial. J Interv Card Electrophysiol. 2015 Oct;44(1):9-16. doi: 10.1007/s10840-015-0030-4. Epub 2015 Jul 2.

  PMID: 26133284 DERIVED

Related Links

• State Research Institute of Circulation Pathology Official Site

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Evgeny Pokushalov, MD, PhD

  State Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: December 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

RU (1)