Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

NCT03845010 | Completed

• 1 other identifier: 10407
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.

Conditions

Ventricular Premature Beats

Outcome Measures

Primary Outcomes (1)

• Successful therapy

  Number of patients reaching succesfull therapy defined as \>80% reduction of of VPB/VT burden after 3 months

  After 3 months

Secondary Outcomes (10)

• VPB/VT burden

  3, 6, 12 months after intervention

• Change in VPB/VT burden

  Before the intervention (baseline) and 3, 6, 12 months after intervention

• The impact in terms of total Quality of Life

  3, 6, 12 months after intervention compared to baseline (before intervention)

• Association between number of VPB/hour and heart rate (HR)/hour during 24-hours Holter- monitoring

  At baseline

• Number of pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in AAD arms with frequent visits and use of 24-hour Holter monitoring

  3, 6 and 12 months after intervention

Study Arms (3)

Sotalol

ACTIVE COMPARATOR

Drug: Sotalol

Flecainide and verapamil

ACTIVE COMPARATOR

Drug: Flecainide and verapamil

Catheter ablation

ACTIVE COMPARATOR

Procedure: Catheter ablation

Interventions

Sotalol DRUG

Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)

Sotalol

Flecainide and verapamil DRUG

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

Flecainide and verapamil

Catheter ablation PROCEDURE

Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine

Catheter ablation

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients willing and capable to provide written informed consent
• 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

You may not qualify if:

• Age \>75 years
• 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

Sponsors & Collaborators

• Maatschap Cardiologie Zwolle: lead

Study Sites (1)

Isala hospital

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Sotalol; Flecainide; Verapamil; Catheter Ablation

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Arif Elvan, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial comparing catheter ablation with two different potent AADs with different engagement mechanisms in a 1:1:1 ratio with a crossover design in the AAD arm.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 19, 2019
• Study Start: February 12, 2019
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: June 28, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)