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

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ClinicalTrials.gov Identifier: NCT03845010
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Maatschap Cardiologie Zwolle

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.

Condition or disease Intervention/treatment Phase
Ventricular Premature Beats Drug: Sotalol Drug: Flecainide and verapamil Procedure: Catheter ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sotalol Drug: Sotalol
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)

Active Comparator: Flecainide and verapamil Drug: 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

Active Comparator: Catheter ablation Procedure: Catheter ablation
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   76 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845010


Contacts
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Contact: Sonja Postma, PhD 0031426 ext 2999 s.postma@diagram-zwolle.nl
Contact: Danielle Haanschoten, MD d.m.haanschoten@isala.nl

Locations
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Netherlands
Isala hospital Recruiting
Zwolle, Netherlands
Contact: Arif Elvan, MD, PhD         
Sponsors and Collaborators
Maatschap Cardiologie Zwolle
Investigators
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Principal Investigator: Arif Elvan, MD, PhD Isala

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Responsible Party: Maatschap Cardiologie Zwolle
ClinicalTrials.gov Identifier: NCT03845010     History of Changes
Other Study ID Numbers: 10407
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Cardiac Complexes, Premature
Ventricular Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Verapamil
Flecainide
Sotalol
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents