ClinicalTrials.gg
Active, not recruitingNCT06898281Updated Apr 24, 2025

Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles

An interventional study of intracardiac echocardiography (ICE)-guided catheter ablation and Pressure-sensing catheter ablation alone in Premature Ventricular Contractions, sponsored by Shanghai Chest Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.

02

Conditions studied

  • Premature Ventricular Contractions

Keywords

  • intracardiac echocardiography
  • papillary muscle-originating premature ventricular contractions
  • premature ventricular contractions
03

In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

This study's planned enrollment of 156 is above the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged ≥18 years.
  • Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles.
  • Symptoms to antiarrhythmic drug therapy.
  • Patients must be capable and willing to provide written for study participation.

Exclusion criteria

Exclusion Criteria:

  • History of cardiac surgery or any prior cardiac interventional procedures.
  • Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
  • Severe hepatic or renal dysfunction:

/ALT >3× (ULN); Serum creatinine (SCr) >3.5 mg/dl or (Ccr) \<30 ml/min.

  • Prior ablation for papillary muscle PVCs.
  • \<1 year.
  • Pregnancy or lactation.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    intracardiac echocardiography (ICE)-guided catheter ablation

    Intracardiac echocardiography (ICE)-guided catheter ablation.

    Procedure: intracardiac echocardiography (ICE)-guided catheter ablation

  • Active comparator
    Pressure-sensing catheter ablation alone

    Pressure-sensing catheter ablation alone.

    Procedure: Pressure-sensing catheter ablation alone

Interventions

  • Procedureintracardiac echocardiography (ICE)-guided catheter ablation

    Intracardiac echocardiography (ICE)-guided catheter ablation.

  • ProcedurePressure-sensing catheter ablation alone

    Pressure-sensing catheter ablation alone

06

What researchers measure

Primary outcomes

  1. 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%).

    Time frame: Patients were followed up at 3 months postoperatively to assess recurrence.

Secondary outcomes

  1. VC burden reduction

    Preoperative VC burden \[%\] - postoperative VC burden \[%\].

    Time frame: Patients were followed up at 3 months postoperatively to assess recurrence.

  2. Total procedure time

    Total procedure time.

    Time frame: From the start to the end of the procedure.

  3. Total fluoroscopy time

    Total fluoroscopy time.

    Time frame: From the start to the end of the procedure.

  4. Major perioperative complications

    Including cardiac tamponade, atrioventricular block, stroke, or pulmonary embolism.

    Time frame: 30 days postoperatively.

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Mar 2026, 11 months after the start.

Of 32 interventional studies with no phase under Ventricular Premature Complexes, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2025
First posted
Mar 27, 2025
StartActual
Mar 23, 2025
Primary completionEst.
Mar 1, 2026
CompletionEst.
Mar 1, 2026
Last update
Apr 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06898281
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, Shenzhen Fuwai Hospital,Chinese Academy of Medical Sciences
Responsible party
Xu Liu (Professor, Shanghai Chest Hospital) — Principal investigator
First posted
Mar 27, 2025
Start date
Mar 23, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Apr 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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