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

July 7, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • State Research Institute of Circulation Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Warfarin
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.
Active Comparator: LAA occluder
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.
Other Names:
  • Watchman
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular death
Time Frame: 12 months
12 months
All stroke
Time Frame: 12 months
12 months
Systemic embolism
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Technical success
Time Frame: 45 days
45 days
Procedure success
Time Frame: 45 days
45 days
30 day major adverse event (MAE)
Time Frame: 30 days
30 days
Left atrial appendage (LAA) coverage
Time Frame: 45 days
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Evgeny Pokushalov, MD, PhD, State Research Institute of Circulation Pathology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA-PR-AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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