Ventricular Premature BeatsECTOPIANCT03845010
Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment
A study testing Sotalol, Flecainide and verapamil and Catheter ablation in people with Ventricular Premature Beats, run by Maatschap Cardiologie Zwolle at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Ventricular Premature Beats
- What is being tested?
- Sotalol, Flecainide and verapamil and Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Feb 2019to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal 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.
Read the 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.
- Conditions
- Ventricular Premature Beats
- Being tested
- Sotalol, Flecainide and verapamil, Catheter ablation
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotalolDrug
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
Flecainide and verapamilDrug
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 ablationProcedure or surgery
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Sotalol | Active comparator | Not described Receives: Drug: Sotalol |
| Flecainide and verapamil | Active comparator | Not described Receives: Drug: Flecainide and verapamil |
| Catheter ablation | Active comparator | Not described Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful therapy
Number of patients reaching succesfull therapy defined as >80% reduction of of VPB/VT burden after 3 months
Measured: After 3 months
Secondary outcomes (10)
VPB/VT burden
Measured: 3, 6, 12 months after intervention
Change in VPB/VT burden
Measurement in different subgroups e.g.: males, pre and post-menopausal women
Measured: Before the intervention (baseline) and 3, 6, 12 months after intervention
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.
Measured: 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
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
Measured: 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
Measured: 3, 6 and 12 months after intervention
QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test
Measured: 4-6 weeks after first administration of AAD
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
Measured: Procedure and 3, 6 and 12 months after intervention
Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement)
Measured: Baseline, 6 and 12 months after intervention
Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil
Measured: 3, 6 and 12 months after intervention
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
Measured: 3, 6 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start12 Feb 2019
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Premature BeatsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maatschap Cardiologie Zwolle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arif Elvan, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845010
- Sponsor's protocol ID
- 10407
- Acronym
- ECTOPIA
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment
- ClinicalTrials.gov ID
- NCT03845010
- Acronym / sponsor ID
- ECTOPIA / 10407
- Conditions
- Ventricular Premature Beats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Maatschap Cardiologie ZwolleUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sotalol | Active comparator | Drug: Sotalol |
| Flecainide and verapamil | Active comparator | Drug: Flecainide and verapamil |
| Catheter ablation | Active comparator | Procedure: Catheter ablation |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotalolPatients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID) | Drug | Sotalol |
| Flecainide and verapamilPatients 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 | Drug | Flecainide and verapamil |
| Catheter ablationPatients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine | Procedure or surgery | Catheter ablation |
Primary outcome
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
10 secondary outcomes
VPB/VT burden
Time frame: 3, 6, 12 months after intervention
Change in VPB/VT burden
Time frame: Before the intervention (baseline) and 3, 6, 12 months after intervention
The impact in terms of total Quality of Life
Time frame: 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
Time frame: 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
Time frame: 3, 6 and 12 months after intervention
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
Complication rate of catheter ablation
Time frame: Procedure and 3, 6 and 12 months after intervention
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Elvan, MD, PhD principal investigator
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sotalol, Flecainide and verapamil and Catheter ablation in people with Ventricular Premature Beats, run by Maatschap Cardiologie Zwolle at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful therapy (time frame: After 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.