Comparison of Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation

NCT02787525 | Completed

• 1 other identifier: 2016-00630
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left atrial closure). A questionnaire is sent to the patients and if there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing/unclear information. The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a similar group of 500 patients with non-valvular AF treated with oral anticoagulation (OAC). In order to compare the two groups and reducing the bias due to confounding variables, a propensity score matching will be performed. Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of intermedium-term clinical outcomes, including thromboembolic events and bleeding complications in patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.

  Clinical sweep follow up, the mean follow-up will be approximately 3 years

Study Arms (2)

A: patients on anticoagulation

Questionnaire to patients with non-valvular atrial fibrillation on OAC or NOAC

Other: Questionnaire

B: patients treated by LAA-Closure

Questionnaire to patient with non-valvular atrial fibrillation who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich

Other: Questionnaire

Interventions

Questionnaire OTHER

A clinical sweep follow up will be performed in all patients of both groups and results will be analyzed. It will be in form of a standardized questionnaire and if necessary telephone interviews asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. For all events, the source documents will be gathered from general physicians, cardiologists, hospitals or registry offices. The questionnaire will be sent by mail to the patients. If information is missing or unclear, patients and if necessary their treating physician will be contacted by phone.

A: patients on anticoagulation; B: patients treated by LAA-Closure

Eligibility Criteria

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

Study Population

* Group A ("OAC"): Patients having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC. * Group B (LAA-closure): Patients who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich

You may qualify if:

• Age \>/= 18 years
• Written informed consent to participate in the study
• Paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
• Group A ("OAC"): Having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC.
• Group B (LAA-closure): Underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich

You may not qualify if:

• No full data on matching criteria (which are described below under "study design")
• Only for group A: Not matched patients having been dropped out after the propensity score matching

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Related Publications (4)

• Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.

  PMID: 25399274 BACKGROUND

• Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.

  PMID: 23583249 BACKGROUND

• Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06.

  PMID: 25604089 BACKGROUND

• Nietlispach F, Gloekler S, Krause R, Shakir S, Schmid M, Khattab AA, Wenaweser P, Windecker S, Meier B. Amplatzer left atrial appendage occlusion: single center 10-year experience. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):283-9. doi: 10.1002/ccd.24872. Epub 2013 Mar 22.

  PMID: 23412815 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Steffen Gloeckler, PD Dr. med

  University hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 1, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share