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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258112
Recruitment Status : Withdrawn (I have changed my center and gone to another center)
First Posted : August 23, 2017
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Abo Elhassan Abdel_Rady, Assiut University

Tracking Information
First Submitted Date  ICMJE August 20, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date March 12, 2020
Estimated Study Start Date  ICMJE March 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2017)
procedural success [ Time Frame: 24 hours after the procedure ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2017)
Recurrence of ventricular arrhythmia after three months [ Time Frame: Three months ]
Appearance of symptoms of palpitation and documentation of recurrence of same type of arrhythmia with prolonged electrocardiographic monitoring in case of symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
Official Title  ICMJE Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Arrythmia
Intervention  ICMJE 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
Study Arms  ICMJE catheter ablation
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: Procedure: Radiofrequency cardiac catheter ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 10, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2017)
57
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03258112
Other Study ID Numbers  ICMJE electrophysiology
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamed Abo Elhassan Abdel_Rady, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Abo Elhassan Abdel-Rady Assiut University
PRS Account Assiut University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP