Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment
NCT ID: NCT03845010
Last Updated: 2023-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2019-02-12
2023-01-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease
NCT05203484
Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation
NCT07201506
Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach
NCT02358746
Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS
NCT05784051
Impact of Catheter Ablation of Frequent Premature Ventricular Complexes in Treating Subtle Left Cardiomyopathy
NCT06864429
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sotalol
Sotalol
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
Flecainide and verapamil
Flecainide and verapamil
Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day
Catheter ablation
Catheter ablation
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sotalol
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
Flecainide and verapamil
Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day
Catheter ablation
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with frequent symptomatic VPB and/or nonsustained VTs with burden ≥ 5% on 24 hour Holter monitor AND
* Absence of structural heart disease (excluded by echocardiogram) AND
* Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND
* Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician.
* For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study
Exclusion Criteria
* Previous catheter ablation therapy for VPB/VT
* Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
* Wolff-parkinson-white (WPW) syndrome
* Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol.
* Left ventricular dysfunction (LV ejection fraction \<55%)
* Estimated glomerular filtration rate \< 50 ml/min/1.73 m2
* Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times ULN at screening
* Untreated hypo- or hyperthyroidism or electrolyte imbalance
* Untreated obstructive sleep apnea
* Patients with history of myocardial infarction or bypass surgery
* More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe)
* Contraindication for any of the antiarrhythmic drugs used in this study
* Enrolment in another clinical study
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age
* Mental or physical inability to participate in the study
* Life expectancy ≤ 12 months
76 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maatschap Cardiologie Zwolle
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arif Elvan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Isala
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Isala hospital
Zwolle, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10407
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.