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Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts

Primary Purpose

Ventricular Arrythmia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiofrequency cardiac catheter ablation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Arrythmia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with idiopathic RVOT/LVOT ventricular arrhythmias in cases of Frequent (PVCs =10.000/24hours), NSVT, or VT Symptomatic, Associated with LV dysfunction (no explained with any cause other than VAs) or Resistance, patient intolerance or patient refusal of drug therapy

Exclusion Criteria:

  • Presence of coronary artery disease, valvular heart disease or any other underlying causes
  • arrhythmia not originating from cardiac outflow tracts

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    catheter ablation

    Arm Description

    all patients indicated for catheter ablation of RVOT or LVOT ventricular arrhythmia are included in one arm for electrophysiological diagnosis of the origin of arrhythmia then for radiofrequency catheter ablation

    Outcomes

    Primary Outcome Measures

    procedural success
    success of the procedure in ablation of ventricular arrhythmia with termination of ventricular arrhythmia, absence of induction of arrhythmia and 24 hours electrocardiographic monitoring after the procedure documenting absence of ventricular arrhythmia

    Secondary Outcome Measures

    Recurrence of ventricular arrhythmia after three months
    Appearance of symptoms of palpitation and documentation of recurrence of same type of arrhythmia with prolonged electrocardiographic monitoring in case of symptoms

    Full Information

    First Posted
    August 20, 2017
    Last Updated
    March 10, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03258112
    Brief Title
    Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
    Official Title
    Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    I have changed my center and gone to another center
    Study Start Date
    March 2017 (Anticipated)
    Primary Completion Date
    April 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Ventricular arrhythmias arising from cardiac outflow tract affect quality of life and can cause decrease in left ventricular ejection fraction. Drugs used for treating those arrhytmias may be ineffective or may have side effects. Radiofrequency catheter ablation can be used safely for treatment of outflow tract arrhythmias. There are different sites where those ventricular arrhythmias may originates, each site has different electrocardiographic characteristics, different procedural success rates and challenges in localization and ablation.
    Detailed Description
    The right and left ventricular outflow tracts (RVOT/LVOT) are the most common sites of origin for idiopathic ventricular tachycardia (VT) and premature ventricular contractions (PVCs) in patients without structural heart disease.1 Frequent PVCs was associated with PVC-induced cardiomyopathy, and radiofrequency (RF) catheter ablation of frequent PVCs was associated with improvement of left ventricular ejection fraction (LVEF).2 The most common underlying pathophysiological mechanism was identified to be triggered activity and RF catheter ablation treatment is highly effective with low complication rates.1,3 Drug therapy has limited effectiveness (in case β-blockers and calcium-channel blockers) or drug-related side effects ( in case of flecainide, propafenone and amiodarone).4 RF catheter ablation is recommended in cases of high PVC burden associated with decreased LV ejection fraction (LVEF) or in highly symptomatic patients despite optimal drug therapy.3 Although the RVOT is the most common site (about 70-80% of cases) for idiopathic VAs1,5, only few studies have reported on the prevalence and RF catheter ablation of ventricular arrhythmias (VAs) arising from the pulmonary artery (21-46% among the RVOT VAs)6 and even less prevalence is reported in VAs arising from the pulmonary sinus cusps (11%).7 Compared with VAs originating from the RVOT, ablation of LVOT-VAs is more complex and reported to be 12-45% of all idiopathic VAs.8-11 The success rate of ablation of LVOT-VA sites was previously reported to be lower (55-60%) without using antegrade/transseptal approaches.12,4 Rarely, it requires epicardial ablation via the GCV/AIV or subxiphoid puncture.13,14 There are some cases in which RF catheter ablation cannot successfully be performed from either LVOT or RVOT. In such cases the VAs may originate from the LV-summit which is the most common site of idiopathic epicardial VAs from the LVOT region.13 Although most idiopathic VAs originating from the cardiac OTs are suitable targets for endocardial RF catheter ablation, a small percentage of failures in these patients may be because of an inaccessible site of origin from epicardial or intramural septal locations.15The identification, mapping and RF catheter ablation of these idiopathic VAs may be challenging for the electrophysiologist and need special consideration.16

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventricular Arrythmia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    catheter ablation
    Arm Type
    Other
    Arm Description
    all patients indicated for catheter ablation of RVOT or LVOT ventricular arrhythmia are included in one arm for electrophysiological diagnosis of the origin of arrhythmia then for radiofrequency catheter ablation
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiofrequency cardiac catheter ablation
    Intervention Description
    procedure used for ablation of ventricular arrhythmia using catheters introduced to target sites percutaneously through venous or arterial systems using radiofrequency power
    Primary Outcome Measure Information:
    Title
    procedural success
    Description
    success of the procedure in ablation of ventricular arrhythmia with termination of ventricular arrhythmia, absence of induction of arrhythmia and 24 hours electrocardiographic monitoring after the procedure documenting absence of ventricular arrhythmia
    Time Frame
    24 hours after the procedure
    Secondary Outcome Measure Information:
    Title
    Recurrence of ventricular arrhythmia after three months
    Description
    Appearance of symptoms of palpitation and documentation of recurrence of same type of arrhythmia with prolonged electrocardiographic monitoring in case of symptoms
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with idiopathic RVOT/LVOT ventricular arrhythmias in cases of Frequent (PVCs =10.000/24hours), NSVT, or VT Symptomatic, Associated with LV dysfunction (no explained with any cause other than VAs) or Resistance, patient intolerance or patient refusal of drug therapy Exclusion Criteria: Presence of coronary artery disease, valvular heart disease or any other underlying causes arrhythmia not originating from cardiac outflow tracts
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Abo Elhassan Abdel-Rady
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Latchamsetty R, Yokokawa M, Morady F, Kim HM, Mathew S, Tilz R, et al. Multicenter outcomes for catheter ablation of idiopathic premature ventricular complexes. J Am Coll Cardiol EP 2015; 1: 116 - 123
    Results Reference
    background
    Citation
    Kumagai K. Idiopathic ventricular arrhythmias arising from the left ventricular outflow tract: Tips and tricks. J Arrythmia 2014; 30: 211 - 221
    Results Reference
    background
    PubMed Identifier
    26320108
    Citation
    Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.
    Results Reference
    result
    PubMed Identifier
    28708198
    Citation
    Wojdyla-Hordynska A, Kowalski O, Hordynski GJ, Dinov B, Sommer P, Hindricks G, Feusette P, Arya A. The effect of radiofrequency catheter ablation of frequent premature ventricular complexes and arrhythmia burden on left ventricular function. Kardiol Pol. 2017;75(7):698-704. doi: 10.5603/KP.a2017.0058.
    Results Reference
    result
    PubMed Identifier
    25179489
    Citation
    Pedersen CT, Kay GN, Kalman J, Borggrefe M, Della-Bella P, Dickfeld T, Dorian P, Huikuri H, Kim YH, Knight B, Marchlinski F, Ross D, Sacher F, Sapp J, Shivkumar K, Soejima K, Tada H, Alexander ME, Triedman JK, Yamada T, Kirchhof P, Lip GY, Kuck KH, Mont L, Haines D, Indik J, Dimarco J, Exner D, Iesaka Y, Savelieva I; EP-Europace,UK. EHRA/HRS/APHRS expert consensus on ventricular arrhythmias. Heart Rhythm. 2014 Oct;11(10):e166-96. doi: 10.1016/j.hrthm.2014.07.024. Epub 2014 Aug 30. No abstract available.
    Results Reference
    result
    PubMed Identifier
    23990183
    Citation
    Pytkowski M, Maciag A, Sterlinski M, Jankowska A, Kowalik I, Farkowski MM, Kuteszko R, Zajac D, Firek B, Chmielak Z, Szwed H. Novel algorithm for arrhythmogenic focus localization in patients with right ventricular outflow tract arrhythmias. Cardiol J. 2014;21(3):284-92. doi: 10.5603/CJ.a2013.0111. Epub 2013 Aug 30.
    Results Reference
    result
    PubMed Identifier
    14530199
    Citation
    Timmermans C, Rodriguez LM, Crijns HJ, Moorman AF, Wellens HJ. Idiopathic left bundle-branch block-shaped ventricular tachycardia may originate above the pulmonary valve. Circulation. 2003 Oct 21;108(16):1960-7. doi: 10.1161/01.CIR.0000095026.19339.BB. Epub 2003 Oct 6.
    Results Reference
    result
    PubMed Identifier
    26670064
    Citation
    Liao Z, Zhan X, Wu S, Xue Y, Fang X, Liao H, Deng H, Liang Y, Wei W, Liu Y, Ouyang F. Idiopathic Ventricular Arrhythmias Originating From the Pulmonary Sinus Cusp: Prevalence, Electrocardiographic/Electrophysiological Characteristics, and Catheter Ablation. J Am Coll Cardiol. 2015 Dec 15;66(23):2633-2644. doi: 10.1016/j.jacc.2015.09.094.
    Results Reference
    result
    PubMed Identifier
    25633492
    Citation
    Kamioka M, Mathew S, Lin T, Metzner A, Rillig A, Deiss S, Rausch P, Lemes C, Makimoto H, Hu H, Liang D, Wissner E, Tilz RR, Kuck KH, Ouyang F. Electrophysiological and electrocardiographic predictors of ventricular arrhythmias originating from the left ventricular outflow tract within and below the coronary sinus cusps. Clin Res Cardiol. 2015 Jul;104(7):544-54. doi: 10.1007/s00392-015-0817-4. Epub 2015 Jan 30.
    Results Reference
    result
    PubMed Identifier
    19808434
    Citation
    Yamada T, Litovsky SH, Kay GN. The left ventricular ostium: an anatomic concept relevant to idiopathic ventricular arrhythmias. Circ Arrhythm Electrophysiol. 2008 Dec;1(5):396-404. doi: 10.1161/CIRCEP.108.795948. No abstract available.
    Results Reference
    result
    PubMed Identifier
    24795340
    Citation
    Ouyang F, Mathew S, Wu S, Kamioka M, Metzner A, Xue Y, Ju W, Yang B, Zhan X, Rillig A, Lin T, Rausch P, Deiss S, Lemes C, Tonnis T, Wissner E, Tilz RR, Kuck KH, Chen M. Ventricular arrhythmias arising from the left ventricular outflow tract below the aortic sinus cusps: mapping and catheter ablation via transseptal approach and electrocardiographic characteristics. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):445-55. doi: 10.1161/CIRCEP.114.001690. Epub 2014 May 2. Erratum In: Circ Arrhythm Electrophysiol. 2014 Oct;7(5):996.
    Results Reference
    result
    PubMed Identifier
    11823089
    Citation
    Ouyang F, Fotuhi P, Ho SY, Hebe J, Volkmer M, Goya M, Burns M, Antz M, Ernst S, Cappato R, Kuck KH. Repetitive monomorphic ventricular tachycardia originating from the aortic sinus cusp: electrocardiographic characterization for guiding catheter ablation. J Am Coll Cardiol. 2002 Feb 6;39(3):500-8. doi: 10.1016/s0735-1097(01)01767-3.
    Results Reference
    result
    PubMed Identifier
    20855374
    Citation
    Yamada T, McElderry HT, Doppalapudi H, Okada T, Murakami Y, Yoshida Y, Yoshida N, Inden Y, Murohara T, Plumb VJ, Kay GN. Idiopathic ventricular arrhythmias originating from the left ventricular summit: anatomic concepts relevant to ablation. Circ Arrhythm Electrophysiol. 2010 Dec;3(6):616-23. doi: 10.1161/CIRCEP.110.939744. Epub 2010 Sep 20.
    Results Reference
    result
    PubMed Identifier
    14689119
    Citation
    Ouyang F, Bansch D, Schaumann A, Ernst S, Linder C, Falk P, Hachiya H, Kuck KH, Antz M. Catheter ablation of subepicardial ventricular tachycardia using electroanatomic mapping. Herz. 2003 Nov;28(7):591-7. doi: 10.1007/s00059-003-2494-8.
    Results Reference
    result
    PubMed Identifier
    22407415
    Citation
    Yokokawa M, Good E, Chugh A, Pelosi F Jr, Crawford T, Jongnarangsin K, Latchamsetty R, Oral H, Morady F, Bogun F. Intramural idiopathic ventricular arrhythmias originating in the intraventricular septum: mapping and ablation. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):258-63. doi: 10.1161/CIRCEP.111.967257. Epub 2012 Mar 9.
    Results Reference
    result
    PubMed Identifier
    27074752
    Citation
    Heeger CH, Hayashi K, Kuck KH, Ouyang F. Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From the Cardiac Outflow Tracts - Recent Insights and Techniques for the Successful Treatment of Common and Challenging Cases. Circ J. 2016 Apr 25;80(5):1073-86. doi: 10.1253/circj.CJ-16-0293. Epub 2016 Apr 13.
    Results Reference
    result

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    Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts

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