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Completed

NCT Number: NCT03845010

Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

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.

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Key information

Conditions

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

Age range

76 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala hospital

Zwolle, Netherlands

About this study

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Mental or physical inability to participate in the study
  • Life expectancy ≤ 12 months

Treatment and study plan

Sotalol

Drug

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

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

Catheter ablation

Procedure

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

Primary outcomes

  1. Successful therapy

    Time frame: After 3 months

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

Secondary outcomes

  1. VPB/VT burden

    Time frame: 3, 6, 12 months after intervention

  2. Change in VPB/VT burden

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

    Measurement in different subgroups e.g.: males, pre and post-menopausal women

  3. The impact in terms of total Quality of Life

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

    Use of the University of Toronto AF severity scale (AFSS) questionnaire to measure Quality of Life. The total score range is 0-35. Seven questions in total with a maximum score of 5 points per question.

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

    Time frame: At baseline

    A scatterplot will be made in order to depict the association between the number of VBP/hour and heart rate (HR)/hour during 24-hour Holter-monitoring

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

    Time frame: 3, 6 and 12 months after intervention

  6. QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test

    Time frame: 4-6 weeks after first administration of AAD

  7. Complication rate of catheter ablation

    Time frame: Procedure and 3, 6 and 12 months after intervention

    In all patients with special interest to the subgroup of patients with anatomically challenging origin of (non-RVOT) VPB/VTs

  8. Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement)

    Time frame: Baseline, 6 and 12 months after intervention

  9. Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil

    Time frame: 3, 6 and 12 months after intervention

  10. Divide patients in three groups depending on HR dependency of VPB/VT and compare absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil

    Time frame: 3, 6 and 12 months after intervention

Sponsors and collaborators

Lead sponsor

Maatschap Cardiologie Zwolle

Other

Registry information

Official study title

Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment

Acronym: ECTOPIA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 19, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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