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

Ventricular Arrythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03258112
• Other study ID #: electrophysiology
• Status: Withdrawn
• Phase: N/A
• Start date: March 2017
• Est. completion date: November 2021

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ventricular Arrythmia

Intervention

Procedure:
• Radiofrequency cardiac catheter ablation
procedure used for ablation of ventricular arrhythmia using catheters introduced to target sites percutaneously through venous or arterial systems using radiofrequency power

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (16)

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( — View 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 ve — View Citation

Kumagai K. Idiopathic ventricular arrhythmias arising from the left ventricular outflow tract: Tips and tricks. J Arrythmia 2014; 30: 211 - 221

Latchamsetty R, Yokokawa M, Morady F, Kim HM, Mathew S, Tilz R, Kuck KH, Nagashima K, Tedrow U, Stevenson WG, Yu R, Tung R, Shivkumar K, Sarrazin JF, Arya A, Hindricks G, Vunnam R, Dickfeld T, Daoud EG, Oza NM, Bogun F. Multicenter Outcomes for Catheter Ablation of Idiopathic Premature Ventricular Complexes. JACC Clin Electrophysiol. 2015 Jun;1(3):116-123. doi: 10.1016/j.jacep.2015.04.005. Epub 2015 Apr 27. — View 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 Ablatio — View Citation

Ouyang F, Bänsch 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. — View 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. — View 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, Tönnis T, Wissner E, Tilz RR, Kuck KH, Chen M. Ventricular arrhythmias arising from the left ventricular outflow tract below the aorti — View 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 — View Citation

Priori SG, Blomström-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, Norekvål TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Docume — View 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. 20 — View 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. Epub 2003 Oct 6. — View 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. — View 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. Review. — View 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 — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours after the procedure
Secondary	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	Three months