Heart DiseasesPhase 3CAT-PVCNCT02924285
Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease
A Phase 3 study testing Procedure (Radiofrequency catheter ablation) and Amiodarone in people with Heart Diseases and Cardiomyopathies, run by University of Leipzig at 1 site in Germany.
Trial summary
For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural heart disease the current European Guidelines for the management of patients with ventricular arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as amiodarone with a class IIa… Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Heart Diseases, Cardiomyopathies, Ventricular Premature Complexes
- What is being tested?
- Procedure (Radiofrequency catheter ablation) and Amiodarone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 4 Mar 2021
- Phase
- Phase 3
- 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 18 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Structural heart disease with or without left ventricular dysfunction with
- PVCs on Holter monitoring (burden >10.000/d) AND/OR
- PVCs on Holter monitoring correlating with symptoms AND/OR
- Reduction of biventricular pacing <92% in subjects with implanted cardiac resynchronization therapy (CRT) device
- Age: 18-87 years
- Willing and capable of giving informed consent
Who cannot join
- Previous ablation procedure or amiodarone for PVC without success
- New York Heart Association (NYHA) functional class IV
- Intracardial thrombus
- Pulmonary fibrosis
- Liver cirrhosis ≥ CHILD B
- Manifest hyper- or hypothyreoidism
Show all 12Show fewer
- Long QT (QTc > 500 ms if QRS<120 ms, if QRS>120 ms according to QTRR, QRS formula)
- Sick sinus syndrome with symptomatic bradycardia <55 bpm or AV node conduction delay without implanted pacing device
- Known side effects under amiodarone or iodine
- Idiopathic angioedema
- Comedication with known risk for torsade-de-pointes tachycardia
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAT-PVC Trial Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease: a Randomized Trial
For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural heart disease the current European Guidelines for the management of patients with ventricular arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as amiodarone with a class IIa indication. Due to the lack of randomized data this study investigates the comparison of catheter ablation and amiodarone for PVC treatment in patients with structural heart disease. Therefore, patients will be randomized to one of two treatment strategies: 1) catheter ablation, or 2) amiodarone.
Read the detailed description
Premature ventricular contractions (PVCs) are frequently encountered in patients with or without structural heart disease. Even though PVCs in healthy subjects are considered to be a benign arrhythmia. There is also evidence for the risk of a reversible cardiomyopathy due to the PVC-induced inter- and intraventricular dyssynchrony. Data show that elimination of PVCs by catheter ablation leads to an improvement of left ventricular dysfunction. In one-half of the heart failure patients frequent PVCs occur with more than 1000/24 h. In patients with structural heart disease premature ventricular contractions (PVCs) lead to an increased mortality risk with only a burden of 10 PVC per hour. Further decreasing of left ventricular function and worsening of heart failure are described. Therefore, therapy of frequent monomorphic PVCs is recommended in these subjects. Beta-blockers as part of standard therapy often remain ineffective or may lead to a paradoxic effect in patients with bradycardia. A limiting factor for selection of antiarrhythmic drug due to increasing mortality is the presence of structural heart disease. So in the most cases amiodarone is indicated. There are data showing improvement of LV function after suppression of PVCs by amiodarone with a significant reduction of the PVC burden in comparison to baseline. However, the adverse effects of amiodarone are well-known especially in long-term therapy. On the other hand, radiofrequency catheter ablation is a widely applied and safe treatment option for PVCs with a high acute success rate of up to 90% PVC reduction in various circumstances like pre-existing heart failure and post myocardial infarction subjects. Some small-sample studies show the benefit of catheter ablation in subjects with depressed LV function. To date, there are no randomized data for comparison of catheter ablation and amiodarone for therapy of PVCs in patients with structural heart disease.
- Being tested
- Procedure (Radiofrequency catheter ablation), Amiodarone
- Medical subject headings
- Heart Diseases, Cardiomyopathies, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure (Radiofrequency catheter ablation)Procedure or surgery
Radiofrequency catheter ablation
AmiodaroneDrug
Amiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as:
Antiarrhythmic Drug Amiodarone
| Study group | Role | What they receive |
|---|---|---|
| Procedure | Active comparator | Radiofrequency catheter ablation Receives: Procedure: Procedure (Radiofrequency catheter ablation) |
| Antiarrhythmic Drug | Active comparator | Amiodarone Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease
difference of the PVC burden in a 24 h Holter registration after 6 weeks and at baseline expressed as the amount of the baseline value ΔVES_r = (VES_6 - VES_0) / VES_0
Measured: Baseline and after 6 weeks
Secondary outcomes (9)
Change in quality of life (QoL) score according EQ-5D questionnaire
Measured: Baseline, after 6 weeks and 12 months
Change in 6 minute walking distance
Measured: Baseline, after 6 weeks and 12 months
Change in left ventricular ejection fraction (LVEF)
Measured: Baseline, after 6 weeks and 12 months
Change in serum NT-proBNP level
Measured: Baseline, after 6 weeks and 12 months
Change in New York Heart Association (NYHA) functional class
Measured: Baseline, after 6 weeks and 12 months
Occurrence of cardiovascular related hospitalization
Measured: after 6 weeks and 12 months
Occurrence of drug adverse effects
Measured: after 6 weeks and 12 months
Occurrence of procedure related complications
Measured: after 6 weeks and 12 months
Difference of the PVC burden in a 24 h Holter registration after 12 months and at baseline expressed as the amount of the baseline value
Measured: Baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Nov 2017
- Primary completion30 Dec 2020
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Helios Health Institute GmbH, Abbott Medical Devices, Zentrum für Klinische Studien Leipzig
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, MD, Principal investigator, Heart Center Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924285
- Sponsor's protocol ID
- CAT-PVC01
- Acronym
- CAT-PVC
- Status last verified
- Jul 2021
- First submitted
- 4 Oct 2016
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAT-PVC Trial Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02924285
- Acronym / sponsor ID
- CAT-PVC / CAT-PVC01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Helios Health Institute GmbH, Abbott Medical Devices, Zentrum für Klinische Studien Leipzig
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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.
For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural heart disease the current European Guidelines for the management of patients with ventricular arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as amiodarone with a class IIa indication. Due to the lack of randomized data this study investigates the comparison of catheter ablation and amiodarone for PVC treatment in patients with structural heart disease. Therefore, patients will be randomized to one of two treatment strategies: 1) catheter ablation, or 2) amiodarone.
Detailed description
Premature ventricular contractions (PVCs) are frequently encountered in patients with or without structural heart disease. Even though PVCs in healthy subjects are considered to be a benign arrhythmia. There is also evidence for the risk of a reversible cardiomyopathy due to the PVC-induced inter- and intraventricular dyssynchrony. Data show that elimination of PVCs by catheter ablation leads to an improvement of left ventricular dysfunction. In one-half of the heart failure patients frequent PVCs occur with more than 1000/24 h. In patients with structural heart disease premature ventricular contractions (PVCs) lead to an increased mortality risk with only a burden of 10 PVC per hour. Further decreasing of left ventricular function and worsening of heart failure are described. Therefore, therapy of frequent monomorphic PVCs is recommended in these subjects. Beta-blockers as part of standard therapy often remain ineffective or may lead to a paradoxic effect in patients with bradycardia. A limiting factor for selection of antiarrhythmic drug due to increasing mortality is the presence of structural heart disease. So in the most cases amiodarone is indicated. There are data showing improvement of LV function after suppression of PVCs by amiodarone with a significant reduction of the PVC burden in comparison to baseline. However, the adverse effects of amiodarone are well-known especially in long-term therapy. On the other hand, radiofrequency catheter ablation is a widely applied and safe treatment option for PVCs with a high acute success rate of up to 90% PVC reduction in various circumstances like pre-existing heart failure and post myocardial infarction subjects. Some small-sample studies show the benefit of catheter ablation in subjects with depressed LV function. To date, there are no randomized data for comparison of catheter ablation and amiodarone for therapy of PVCs in patients with structural heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure | Active comparator | Procedure: Procedure (Radiofrequency catheter ablation)Radiofrequency catheter ablation |
| Antiarrhythmic Drug | Active comparator | Drug: AmiodaroneAmiodarone |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Structural heart disease with or without left ventricular dysfunction with
- PVCs on Holter monitoring (burden >10.000/d) AND/OR
- PVCs on Holter monitoring correlating with symptoms AND/OR
- Reduction of biventricular pacing <92% in subjects with implanted cardiac resynchronization therapy (CRT) device
- Age: 18-87 years
Key exclusion criteria (12 listed)
- Previous ablation procedure or amiodarone for PVC without success
- New York Heart Association (NYHA) functional class IV
- Intracardial thrombus
- Pulmonary fibrosis
- Liver cirrhosis ≥ CHILD B
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 |
|---|---|---|
| Procedure (Radiofrequency catheter ablation)Radiofrequency catheter ablation | Procedure or surgery | Procedure |
| AmiodaroneAmiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as: Antiarrhythmic Drug Amiodarone | Drug | Antiarrhythmic Drug |
Primary outcome
Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease
Time frame: Baseline and after 6 weeks
difference of the PVC burden in a 24 h Holter registration after 6 weeks and at baseline expressed as the amount of the baseline value ΔVES_r = (VES_6 - VES_0) / VES_0
9 secondary outcomes
Change in quality of life (QoL) score according EQ-5D questionnaire
Time frame: Baseline, after 6 weeks and 12 months
Change in 6 minute walking distance
Time frame: Baseline, after 6 weeks and 12 months
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline, after 6 weeks and 12 months
Change in serum NT-proBNP level
Time frame: Baseline, after 6 weeks and 12 months
Change in New York Heart Association (NYHA) functional class
Time frame: Baseline, after 6 weeks and 12 months
Occurrence of cardiovascular related hospitalization
Time frame: after 6 weeks and 12 months
Occurrence of drug adverse effects
Time frame: after 6 weeks and 12 months
Occurrence of procedure related complications
Time frame: after 6 weeks and 12 months
Difference of the PVC burden in a 24 h Holter registration after 12 months and at baseline expressed as the amount of the baseline value
Time frame: Baseline and after 12 months
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 22 Jul 2021.
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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.
Gerhard Hindricks, MD principal investigator
Heart Center Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procedure (Radiofrequency catheter ablation) and Amiodarone in people with Heart Diseases and Cardiomyopathies, run by University of Leipzig at 1 site in Germany.
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 12 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 22 Jul 2021. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease (time frame: Baseline and after 6 weeks). 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 22 Jul 2021.