Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007309

Trial Description

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Title

A Prospective, Non-randomized, Double Blind Multicenter Study to Assess Endothelial Function Using Endo-PAT2000 and Its Correlation to Clinical Outcome Following Ablation in Patients With Atrial Fibrillation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to assess whether normal endothelial function in patients with
Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable
clinical outcome and maintaining sinus rhythm following ablation

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Brief Summary in Scientific Language

In the recent years, increasing evidence is linking inflammation to AFib. In addition, it
has been shown that ablation improves endothelial function, suggesting that AFib might be
associated with the etiology of endothelial dysfunction.

The objective of this study is to assess endothelial function using Endo-PAT2000 and its
correlation to clinical outcome following ablation of patients with Atrial Fibrillation
(AFib).

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Organizational Data

  •   DRKS00007309
  •   2015/09/23
  •   2014/04/30
  •   no
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Secondary IDs

  •   NCT02129842  (ClinicalTrials.gov)
  •   Endo-AFib-001  (Itamar-Medical, Israel)
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Health Condition or Problem studied

  •   Atrial Fibrillation
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Freedom from AF/AFL/AT off antiarrhythmic drugs therapy; time frame: 12 months

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Secondary Outcome

- Acute procedural success: Pulmonary veins isolation; time frame: 12 months
- 75% reduction in the number/duration of AFib episodes; time frame: 12 months

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Countries of Recruitment

  •   United States
  •   Germany
  •   Israel
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/05/31
  •   150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- All patients with AF considered eligible for ablation treatment may be included in
this study (following unsuccessful attempts with AAD).

- Patients on optimal anticoagulation therapy

- The minimum AF documentation required as defined by the Heart Rhythm Society

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Exclusion Criteria

- Patients age below 18 years

- Cases with extremely abnormal anatomy (i.e., inverted heart)

- Hypo or hyperthyroidism

- Hypertrophic myocardiopathy

- Moderate or severe mitral valve disease or mitral prosthetic valve

- Ejection fraction less than 30%

- Left atrial anteroposterior diameter more than 50 mm.

- Previous atrial fibrillation ablation occurred less than 6 months prior

- Left atrium thrombus

- Acute infective disease or sepsis in the last 3 months

- Pregnant women

- Acute myocardial infarction in last 3 months

- Reduced expectancy of life (less than 12 months)

- Patient participating in another clinical study that investigates a drug or device

- Psychologically unstable patient or denies to give informed consent

- Deformities of the digits of the upper extremities, which preclude adequate signal
acquisition

- Patients under the effect of short-acting Nitroglycerin (3 hours washout period)

- Patient suffering from a medical condition prohibiting blood flow occlusion in both
arms

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Addresses

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    • Itamar-Medical, Israel
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1.; 22389422
  •   Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-47. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3.; 23563126
  •   Pokushalov E, Romanov A, Artyomenko S, Turov A, Shugayev P, Shirokova N, Katritsis DG. Ganglionated plexi ablation for longstanding persistent atrial fibrillation. Europace. 2010 Mar;12(3):342-6. doi: 10.1093/europace/euq014.; 20173210
  •   Boos CJ, Anderson RA, Lip GY. Is atrial fibrillation an inflammatory disorder? Eur Heart J. 2006 Jan;27(2):136-49. Epub 2005 Nov 8. Review.; 16278230
  •   Yoshino S, Yoshikawa A, Hamasaki S, Ishida S, Oketani N, Saihara K, Okui H, Kuwahata S, Fujita S, Ichiki H, Ueya N, Iriki Y, Maenosono R, Miyata M, Tei C. Atrial fibrillation-induced endothelial dysfunction improves after restoration of sinus rhythm. Int J Cardiol. 2013 Sep 30;168(2):1280-5. doi: 10.1016/j.ijcard.2012.12.006. Epub 2012 Dec 24.; 23269316
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.