Premature Ventricular ContractionsNCT06898281
Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles
A study testing intracardiac echocardiography (ICE)-guided catheter ablation and Pressure-sensing catheter ablation alone in people with Premature Ventricular Contractions, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Contractions
- What is being tested?
- intracardiac echocardiography (ICE)-guided catheter ablation and Pressure-sensing catheter ablation alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years.
- Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles.
- Symptoms refractory to antiarrhythmic drug therapy.
- Patients must be capable and willing to provide written informed consent for study participation.
Who cannot join
- History of cardiac surgery or any prior cardiac interventional procedures.
- Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- Severe hepatic or renal dysfunction:
- AST/ALT >3× upper limit of normal (ULN); Serum creatinine (SCr) >3.5 mg/dl or creatinine clearance (Ccr) <30 ml/min.
- Prior ablation for papillary muscle PVCs.
- Life expectancy <1 year.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles: A Randomized Controlled Trial
This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.
- Conditions
- Premature Ventricular Contractions
- Being tested
- intracardiac echocardiography (ICE)-guided catheter ablation, Pressure-sensing catheter ablation alone
- Keywords
- intracardiac echocardiography, papillary muscle-originating premature ventricular contractions, premature ventricular contractions
- 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.
intracardiac echocardiography (ICE)-guided catheter ablationProcedure or surgery
Intracardiac echocardiography (ICE)-guided catheter ablation.
Pressure-sensing catheter ablation aloneProcedure or surgery
Pressure-sensing catheter ablation alone
| Study group | Role | What they receive |
|---|---|---|
| intracardiac echocardiography (ICE)-guided catheter ablation | Experimental | Intracardiac echocardiography (ICE)-guided catheter ablation. Receives: Procedure: intracardiac echocardiography (ICE)-guided catheter ablation |
| Pressure-sensing catheter ablation alone | Active comparator | Pressure-sensing catheter ablation alone. Receives: Procedure: Pressure-sensing catheter ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from VC recurrence
Freedom from VC recurrence (defined as a ≥80% reduction in VC burden, calculated as [number of VCs per 24 hours / total number of heartbeats per 24 hours] × 100%).
Measured: Patients were followed up at 3 months postoperatively to assess recurrence.
Secondary outcomes (4)
VC burden reduction
Preoperative VC burden [%] - postoperative VC burden [%].
Measured: Patients were followed up at 3 months postoperatively to assess recurrence.
Total procedure time
Total procedure time.
Measured: From the start to the end of the procedure.
Total fluoroscopy time
Total fluoroscopy time.
Measured: From the start to the end of the procedure.
Major perioperative complications
Including cardiac tamponade, atrioventricular block, stroke, or pulmonary embolism.
Measured: 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start23 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ContractionsStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Anhui Province, The First People's Hospital of Hefei, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898281
- Sponsor's protocol ID
- ICE-PMPVC
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06898281
- Acronym / sponsor ID
- ICE-PMPVC
- Conditions
- Premature Ventricular Contractions
- Keywords
- intracardiac echocardiography, papillary muscle-originating premature ventricular contractions, premature ventricular contractions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Anhui Province, The First People's Hospital of Hefei, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Mar 2025 (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.
This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracardiac echocardiography (ICE)-guided catheter ablation | Experimental | Procedure: intracardiac echocardiography (ICE)-guided catheter ablationIntracardiac echocardiography (ICE)-guided catheter ablation. |
| Pressure-sensing catheter ablation alone | Active comparator | Procedure: Pressure-sensing catheter ablation alonePressure-sensing catheter ablation alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years.
- Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles.
- Symptoms refractory to antiarrhythmic drug therapy.
- Patients must be capable and willing to provide written informed consent for study participation.
Key exclusion criteria (7 listed)
- History of cardiac surgery or any prior cardiac interventional procedures.
- Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- Severe hepatic or renal dysfunction:
- AST/ALT >3× upper limit of normal (ULN); Serum creatinine (SCr) >3.5 mg/dl or creatinine clearance (Ccr) <30 ml/min.
- Prior ablation for papillary muscle PVCs.
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 |
|---|---|---|
| intracardiac echocardiography (ICE)-guided catheter ablationIntracardiac echocardiography (ICE)-guided catheter ablation. | Procedure or surgery | intracardiac echocardiography (ICE)-guided catheter ablation |
| Pressure-sensing catheter ablation alonePressure-sensing catheter ablation alone | Procedure or surgery | Pressure-sensing catheter ablation alone |
Primary outcome
Freedom from VC recurrence
Time frame: Patients were followed up at 3 months postoperatively to assess recurrence.
Freedom from VC recurrence (defined as a ≥80% reduction in VC burden, calculated as [number of VCs per 24 hours / total number of heartbeats per 24 hours] × 100%).
4 secondary outcomes
VC burden reduction
Time frame: Patients were followed up at 3 months postoperatively to assess recurrence.
Total procedure time
Time frame: From the start to the end of the procedure.
Total fluoroscopy time
Time frame: From the start to the end of the procedure.
Major perioperative complications
Time frame: 30 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracardiac echocardiography (ICE)-guided catheter ablation and Pressure-sensing catheter ablation alone in people with Premature Ventricular Contractions, run by Shanghai Chest Hospital at 1 site in China.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Freedom from VC recurrence (time frame: Patients were followed up at 3 months postoperatively to assess recurrence.). 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 24 Apr 2025.