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Atrial FibrillationWATCH-HDNCT03446794

Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

An observational study of Atrial Fibrillation and Heart Diseases, run by Fundación EPIC at 20 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Heart Diseases, Renal Disease
What is being tested?
Non Intervention
How many people
300 participants
Where
20 sitesSpain
Study dates
14 Mar 2018to 7 Jan 2022
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis .

Who may be able to join

  • Age> 18 years.
  • Stage V chronic kidney disease (GFR <15 ml / min) in hemodialysis at the time of left atrial appendage closure.
  • History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
  • Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.
  • High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC> 2).
  • The patient has been informed of the characteristics of the study and has provided written informed consent.

Who cannot join

  • Life expectancy < 2 years.
  • Indication for OA different from NVAF.
  • Severe pericardial effusion.
  • Previous percutaneous closure of atrial septal defect.
  • Intracardiac thrombus.
  • Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) > 1.5.
  • The patient refuses to participate in the study.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Santa Creu y Sant Pau

    Barcelona, 08041

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Juan Ramón Jiménez Huelva

    Huelva, 21005

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, 35010

  • Hospital Universitario de León

    León, 24071

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222

  • Hospital Costa del Sol

    Marbella, Málaga, 29603

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Clínica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009

  • Hospital de Vinalopó

    Torrevieja, Alicante, 03293

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Registry of Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention. The aim of the study is to assess the procedural safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial fibrillation (NVAF) and ESCKD on HD.

Read the detailed description

Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention.

Being tested
Non Intervention
Keywords
Left Atrial Appendage Closure, Watchman device
Medical subject headings
Atrial Fibrillation, Heart Diseases, Kidney Diseases, Hemorrhage, Arrhythmias, Cardiac, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non InterventionOther

    Also called Safety and efficacy

    To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD

Study groups in NCT03446794
Study groupRoleWhat they receive
patients with NVAF and ESCKD on HDNot described
Receives: Other: Non Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of all-cause mortality, stroke and bleeding

    Composite: Stroke or Transient Ischemic Attack (TIA), Systemic embolism, Major bleeding event (BARC ≥ 2).

    Systemic embolism, Major bleeding event (BARC ≥ 2)

    Measured: 24 month

Secondary outcomes (3)

  1. Periprocedural major adverse events

    Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization)

    Measured: 2 days

  2. Echocardiographic adverse events during follow up

    Prevalence of device thrombus

    Measured: 24 month

  3. Echocardiographic adverse events during follow up

    Prevalence and severity of residual leak

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2018
  2. Study start14 Mar 2018
  3. Primary completion7 Jan 2022
  4. Study completion7 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
300 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446794
Sponsor's protocol ID
WATCH-HD EPIC-06
Acronym
WATCH-HD
Status last verified
Jun 2022
First submitted
19 Feb 2018
Last updated
24 Jun 2022
Results posted
No
Data monitoring committee
No

Publications

  • Fabbian F, Catalano C, Lambertini D, Tarroni G, Bordin V, Squerzanti R, Gilli P, Di Landro D, Cavagna R. Clinical characteristics associated to atrial fibrillation in chronic hemodialysis patients. Clin Nephrol. 2000 Sep;54(3):234-9.

    PubMed 11020022

  • Vazquez E, Sanchez-Perales C, Borrego F, Garcia-Cortes MJ, Lozano C, Guzman M, Gil JM, Borrego MJ, Perez V. Influence of atrial fibrillation on the morbido-mortality of patients on hemodialysis. Am Heart J. 2000 Dec;140(6):886-90. doi: 10.1067/mhj.2000.111111.

    PubMed 11099992

  • Wizemann V, Tong L, Satayathum S, Disney A, Akiba T, Fissell RB, Kerr PG, Young EW, Robinson BM. Atrial fibrillation in hemodialysis patients: clinical features and associations with anticoagulant therapy. Kidney Int. 2010 Jun;77(12):1098-106. doi: 10.1038/ki.2009.477. Epub 2010 Jan 6.

    PubMed 20054291

  • Winkelmayer WC, Patrick AR, Liu J, Brookhart MA, Setoguchi S. The increasing prevalence of atrial fibrillation among hemodialysis patients. J Am Soc Nephrol. 2011 Feb;22(2):349-57. doi: 10.1681/ASN.2010050459. Epub 2011 Jan 13.

    PubMed 21233416

  • Providencia R, Marijon E, Boveda S, Barra S, Narayanan K, Le Heuzey JY, Gersh BJ, Goncalves L. Meta-analysis of the influence of chronic kidney disease on the risk of thromboembolism among patients with nonvalvular atrial fibrillation. Am J Cardiol. 2014 Aug 15;114(4):646-53. doi: 10.1016/j.amjcard.2014.05.048. Epub 2014 Jun 6.

    PubMed 25001152

  • Seliger SL, Gillen DL, Longstreth WT Jr, Kestenbaum B, Stehman-Breen CO. Elevated risk of stroke among patients with end-stage renal disease. Kidney Int. 2003 Aug;64(2):603-9. doi: 10.1046/j.1523-1755.2003.00101.x.

    PubMed 12846756

  • Zimmerman D, Sood MM, Rigatto C, Holden RM, Hiremath S, Clase CM. Systematic review and meta-analysis of incidence, prevalence and outcomes of atrial fibrillation in patients on dialysis. Nephrol Dial Transplant. 2012 Oct;27(10):3816-22. doi: 10.1093/ndt/gfs416.

    PubMed 23114904

  • Biggers JA, Remmers AR Jr, Glassford DM, Sarles HE, Lindley JD, Fish JC. The risk of anticoagulation in hemodialysis patients. Nephron. 1977;18(2):109-13. doi: 10.1159/000180784.

    PubMed 854139

  • Holden RM, Harman GJ, Wang M, Holland D, Day AG. Major bleeding in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Jan;3(1):105-10. doi: 10.2215/CJN.01810407. Epub 2007 Nov 14.

    PubMed 18003768

  • Elliott MJ, Zimmerman D, Holden RM. Warfarin anticoagulation in hemodialysis patients: a systematic review of bleeding rates. Am J Kidney Dis. 2007 Sep;50(3):433-40. doi: 10.1053/j.ajkd.2007.06.017.

    PubMed 17720522

  • Clase CM, Holden RM, Sood MM, Rigatto C, Moist LM, Thomson BK, Mann JF, Zimmerman DL. Should patients with advanced chronic kidney disease and atrial fibrillation receive chronic anticoagulation? Nephrol Dial Transplant. 2012 Oct;27(10):3719-24. doi: 10.1093/ndt/gfs346.

    PubMed 23114898

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.

    PubMed 28038729

  • Bonde AN, Lip GY, Kamper AL, Hansen PR, Lamberts M, Hommel K, Hansen ML, Gislason GH, Torp-Pedersen C, Olesen JB. Net clinical benefit of antithrombotic therapy in patients with atrial fibrillation and chronic kidney disease: a nationwide observational cohort study. J Am Coll Cardiol. 2014 Dec 16;64(23):2471-82. doi: 10.1016/j.jacc.2014.09.051.

    PubMed 25500231

  • van Latum JC, Koudstaal PJ, Venables GS, van Gijn J, Kappelle LJ, Algra A. Predictors of major vascular events in patients with a transient ischemic attack or minor ischemic stroke and with nonrheumatic atrial fibrillation. European Atrial Fibrillation Trial (EAFT) Study Group. Stroke. 1995 May;26(5):801-6. doi: 10.1161/01.str.26.5.801.

    PubMed 7740570

  • European Atrial Fibrillation Trial Study Group. Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. N Engl J Med. 1995 Jul 6;333(1):5-10. doi: 10.1056/NEJM199507063330102.

    PubMed 7776995

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Heart Diseases, run by Fundación EPIC at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause mortality, stroke and bleeding (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03446794, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.

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