PVC - Premature Ventricular ComplexPAsT-PVCNCT04778696
PASO Automated Template Matching for PVC Ablation
A study testing PASO Pacemapping and Conventional Pacemapping in people with PVC - Premature Ventricular Complex and Cardiomyopathies, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- PVC - Premature Ventricular Complex, Cardiomyopathies, Heart Failure
- What is being tested?
- PASO Pacemapping and Conventional Pacemapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 5 Feb 2018to 1 Oct 2022
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Informed, written consent
- ventricular arrhythmia (PVC or VT) with indication for CA
Who cannot join
- Patients under guardianship or with mental disorders / disabilities
- Polymorphic PVC / VT
- ongoing myocardial ischaemia
- pregnancy
- valve replacement that prevents access to the suspected site of PVC origin
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, 50937
Jakob Lüker, MD, +4922147832396, jakob.lueker@uk-koeln.de
Jakob Lüker, MD
About this study
Official title: PASO - Automated Template Matching for PVC Ablation: A Randomised Clinical Trial
Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial. The Aim of this study is to evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping. A total of 144 pts will be randomised in a 1:1 fashion to PVC ablation guided by conventional pacemapping vs PVC ablation guided by PASO pacemapping. Patients will be follow up with Holter-ECG and TTE after 3 and 12 months.
Read the detailed description
Introduction / Rationale Premature ventricular contractions (PVC) in the otherwise healthy heart are not associated with increased mortality in the absence of a short coupling interval or a compromised left ventricular function and do not require treatment if asymptomatic . Symptomatic idiopathic PVC or VT on the other hand can burden patients with recurring palpitations, dizziness, dyspnea and possibly syncope in cases of fast VT. A reversible decrease in left ventricular function as a result of a high PVC burden has been reported even in patients with no underlying cardiomyopathy . Radiofrequency Ablation (RFA) is a well-established method to treat idiopathic PVC and VT, and is associated with satisfying long-term results. Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial.
Aim of the study To evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping.
Hypothesis PASO guidance during PVC / VT ablation has a significant impact on outcome after catheter ablation of idiopathic PVC / VT.
Study design This study is planned as a two-center trial. All patients presenting for de novo ablation of idiopathic ventricular arrhythmia will be included and randomized in a 1:1 fashion in this open-label, two-center, randomized controlled trial.
In patients randomized to the PASO / intervention group pacemapping will be guided by automated template matching of the PASO module of CARTO3.
In patients randomized to the conventional / control group conventional pacemapping will be employed.
A 3D electroanatomic geometry including activation mapping will be acquired in all patients using CARTO3. Sedation, catheters and monitoring during and after CA, will not differ from standard clinical practice and will be the same for both groups.
Follow-up after 3 and 12 months will assess PVC burden by Holter ECG, symptoms through a standardized questionnaire and LV function by TTE
Duration and study size Based on prior findings ("Impact of Automated Template Matching during PVC Ablation: Results from a Randomized Controlled Trial" Lüker et al. ESC 2014 poster presentation) 144 pts have to be randomized to detect a significant difference with respect to ablation success at follow-up (alpha 0.05, power 80%).
- Conditions
- PVC - Premature Ventricular Complex, Cardiomyopathies, Heart Failure, Ventricular Tachycardia
- Being tested
- PASO Pacemapping, Conventional Pacemapping
- Medical subject headings
- Ventricular Premature Complexes, Cardiomyopathies, Heart Failure, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASO PacemappingProcedure or surgery
Using the PASO pacemapping visualisation module of CARTO3
Conventional PacemappingProcedure or surgery
without visualisation in 3D mapping
| Study group | Role | What they receive |
|---|---|---|
| conventional pace mapping | Active comparator | Conventional PVC pace mapping without visual guidance of PASO Receives: Procedure: Conventional Pacemapping |
| PASO pace mapping | Experimental | PASO pace mapping with visualisation in CARTO3 Receives: Procedure: PASO Pacemapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVC recurrence in Holter ECG
Assessment of PVC as % of total number heart beats in a 24 hours Holter ECG
Measured: 12 weeks after ablation procedure
Secondary outcomes (5)
Symptomatic recurrence
recurrence of PVC according to the patients symptoms
Measured: between 3 and 12 months after ablation
LV ejection fraction assessment (%)
Change in LV ejection fraction after ablation (%)
Measured: between 3 months and 12 months after ablation
Procedure duration
Procedure duration (min)
Measured: From groin puncture to sheath removal
Prcedural fluoroscopy parameters
Fluoroscopy dose (Gy x cm2) and time (min)
Measured: From groin puncture to sheath removal
Procedural ablation parameters
Number of RF lesions (n) and acute ablation success (cessation of PVC)
Measured: From groin puncture to sheath removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start5 Feb 2018
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PVC - Premature Ventricular ComplexStudies 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
- Parallel groups
- Model description
- 1:1 simple randomisation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778696
- Sponsor's protocol ID
- UKK-PASTPVC-2018
- Acronym
- PAsT-PVC
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2018
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASO - Automated Template Matching for PVC Ablation: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04778696
- Acronym / sponsor ID
- PAsT-PVC / UKK-PASTPVC-2018
- Conditions
- PVC - Premature Ventricular Complex, Cardiomyopathies, Heart Failure, Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 3 Mar 2021 (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.
Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial. The Aim of this study is to evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping. A total of 144 pts will be randomised in a 1:1 fashion to PVC ablation guided by conventional pacemapping vs PVC ablation guided by PASO pacemapping. Patients will be follow up with Holter-ECG and TTE after 3 and 12 months.
Detailed description
Introduction / Rationale Premature ventricular contractions (PVC) in the otherwise healthy heart are not associated with increased mortality in the absence of a short coupling interval or a compromised left ventricular function and do not require treatment if asymptomatic . Symptomatic idiopathic PVC or VT on the other hand can burden patients with recurring palpitations, dizziness, dyspnea and possibly syncope in cases of fast VT. A reversible decrease in left ventricular function as a result of a high PVC burden has been reported even in patients with no underlying cardiomyopathy . Radiofrequency Ablation (RFA) is a well-established method to treat idiopathic PVC and VT, and is associated with satisfying long-term results. Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial.
Aim of the study To evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping.
Hypothesis PASO guidance during PVC / VT ablation has a significant impact on outcome after catheter ablation of idiopathic PVC / VT.
Study design This study is planned as a two-center trial. All patients presenting for de novo ablation of idiopathic ventricular arrhythmia will be included and randomized in a 1:1 fashion in this open-label, two-center, randomized controlled trial.
In patients randomized to the PASO / intervention group pacemapping will be guided by automated template matching of the PASO module of CARTO3.
In patients randomized to the conventional / control group conventional pacemapping will be employed.
A 3D electroanatomic geometry including activation mapping will be acquired in all patients using CARTO3. Sedation, catheters and monitoring during and after CA, will not differ from standard clinical practice and will be the same for both groups.
Follow-up after 3 and 12 months will assess PVC burden by Holter ECG, symptoms through a standardized questionnaire and LV function by TTE
Duration and study size Based on prior findings ("Impact of Automated Template Matching during PVC Ablation: Results from a Randomized Controlled Trial" Lüker et al. ESC 2014 poster presentation) 144 pts have to be randomized to detect a significant difference with respect to ablation success at follow-up (alpha 0.05, power 80%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1:1 simple randomisation
| Arm | Type | Receives |
|---|---|---|
| conventional pace mapping | Active comparator | Procedure: Conventional PacemappingConventional PVC pace mapping without visual guidance of PASO |
| PASO pace mapping | Experimental | Procedure: PASO PacemappingPASO pace mapping with visualisation in CARTO3 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Informed, written consent
- ventricular arrhythmia (PVC or VT) with indication for CA
Key exclusion criteria (5 listed)
- Patients under guardianship or with mental disorders / disabilities
- Polymorphic PVC / VT
- ongoing myocardial ischaemia
- pregnancy
- valve replacement that prevents access to the suspected site of PVC origin
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 |
|---|---|---|
| PASO PacemappingUsing the PASO pacemapping visualisation module of CARTO3 | Procedure or surgery | PASO pace mapping |
| Conventional Pacemappingwithout visualisation in 3D mapping | Procedure or surgery | conventional pace mapping |
Primary outcome
PVC recurrence in Holter ECG
Time frame: 12 weeks after ablation procedure
Assessment of PVC as % of total number heart beats in a 24 hours Holter ECG
5 secondary outcomes
Symptomatic recurrence
Time frame: between 3 and 12 months after ablation
LV ejection fraction assessment (%)
Time frame: between 3 months and 12 months after ablation
Procedure duration
Time frame: From groin puncture to sheath removal
Prcedural fluoroscopy parameters
Time frame: From groin puncture to sheath removal
Procedural ablation parameters
Time frame: From groin puncture to sheath removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASO Pacemapping and Conventional Pacemapping in people with PVC - Premature Ventricular Complex and Cardiomyopathies, run by Universitätsklinikum Köln 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Mar 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVC recurrence in Holter ECG (time frame: 12 weeks after ablation procedure). 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 3 Mar 2021.