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Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment (ECTOPIA)

Primary Purpose

Ventricular Premature Beats

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Sotalol

Flecainide and verapamil

Catheter ablation

About this trial

This is an interventional treatment trial for Ventricular Premature Beats

Eligibility Criteria

76 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Isala hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Sotalol

Flecainide and verapamil

Catheter ablation

Arm Description

Outcomes

Primary Outcome Measures

Successful therapy

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

Secondary Outcome Measures

VPB/VT burden

Change in VPB/VT burden

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

The impact in terms of total Quality of Life

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.

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

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

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

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

Complication rate of catheter ablation

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

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

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

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

Full Information

NCT ID

NCT03845010

First Posted

January 17, 2019

Last Updated

June 27, 2023

Sponsor

Maatschap Cardiologie Zwolle

1. Study Identification

Unique Protocol Identification Number

NCT03845010

Brief Title

Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

Acronym

ECTOPIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 12, 2019 (Actual)

Primary Completion Date

January 17, 2023 (Actual)

Study Completion Date

January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maatschap Cardiologie Zwolle

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Premature Beats

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sotalol

Arm Type

Active Comparator

Arm Title

Flecainide and verapamil

Arm Type

Active Comparator

Arm Title

Catheter ablation

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Sotalol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Flecainide and verapamil

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Catheter ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Successful therapy

Description

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

Time Frame

After 3 months

Secondary Outcome Measure Information:

Title

VPB/VT burden

Time Frame

3, 6, 12 months after intervention

Title

Change in VPB/VT burden

Description

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

Time Frame

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

Title

The impact in terms of total Quality of Life

Description

Time Frame

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

Title

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

Description

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

Time Frame

At baseline

Title

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

Title

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

Title

Complication rate of catheter ablation

Description

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

Time Frame

Procedure and 3, 6 and 12 months after intervention

Title

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

Title

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

Title

Time Frame

3, 6 and 12 months after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arif Elvan, MD, PhD

Organizational Affiliation

Isala

Official's Role

Principal Investigator

Facility Information:

Facility Name

Isala hospital

City

Zwolle

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

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Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

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