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Withdrawn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
About this trial
This is an interventional treatment trial for Ventricular Arrythmia
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
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
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Withdrawn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
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Results Reference
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PubMed Identifier
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Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
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