Atrial FibrillationNCT06460831
A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
A study testing Microcatheter and OTW in people with Atrial Fibrillation and Atrial Flutter, run by Shanghai Chest Hospital at 5 sites in China.
Trial summary
The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to: Undergo… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Microcatheter and OTW
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 5 sitesChina
- Study dates
- 15 Jun 2024to 31 Dec 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 18-80 years.
- Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.
- Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.
- New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%
Who cannot join
- Patients with known allergies to alcohol.
- Participants with a history of serious cardiovascular events such as myocardial infarction or stroke within the past three months will be excluded from the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Changshu Hospital of Traditional Chinese Medical
Changshu, 215500
Yanzhe Wang, MD, 18101817225, ncdx2006hu@126.com
Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250000
Xiyao Zhu, MD, ncdx2006hu@126.com
Ren Ji Hospital
Shanghai, Shanghai Municipality, 200030
Xinhua Wang, MD, 18101817225, ncdx2006hu@126.com
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Xu Liu, MD, 18101817225, drliuxu@126.com
Yuhuan Second People's Hospital
Taizhou, Zhejiang, 318000
Qidong Zheng, MD, 18101817225, ncdx2006hu@126.com
About this study
The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:
Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Microcatheter, OTW
- Keywords
- marshall vein, mitral valve isthmus line
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocatheterDevice
The microcatheter group undergoes alcohol ablation using a microcatheter.
OTWDevice
The OTW group undergoes alcohol ablation using an OTW balloon.
| Study group | Role | What they receive |
|---|---|---|
| OTW group | Placebo comparator | Not described Receives: Device: OTW |
| Microcatheter group | Experimental | Not described Receives: Device: Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rate of mitral isthmus block
Efficacy endpoints
Measured: During catheter ablation procedures
Procedural complications
Safety endpoints
Measured: During catheter ablation procedures
Recovery rate of the mitral isthmus line
Long-term primary efficacy endpoints
Measured: beyond 3 months after the ablation procedure.
Secondary outcomes (2)
Procedural characteristics
Measured: Periprocedural period
Hospitalization costs
Measured: Periprocedural period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460831
- Sponsor's protocol ID
- MARSHALL-CATH study
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06460831
- Acronym / sponsor ID
- MARSHALL-CATH study
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- marshall vein, mitral valve isthmus line
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:
Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTW group | Placebo comparator | Device: OTW |
| Microcatheter group | Experimental | Device: Microcatheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 18-80 years.
- Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.
- Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.
- New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%
Key exclusion criteria (2 listed)
- Patients with known allergies to alcohol.
- Participants with a history of serious cardiovascular events such as myocardial infarction or stroke within the past three months will be excluded from the study
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 |
|---|---|---|
| MicrocatheterThe microcatheter group undergoes alcohol ablation using a microcatheter. | Device | Microcatheter group |
| OTWThe OTW group undergoes alcohol ablation using an OTW balloon. | Device | OTW group |
Primary outcome
Acute rate of mitral isthmus block
Time frame: During catheter ablation procedures
Efficacy endpoints
Procedural complications
Time frame: During catheter ablation procedures
Safety endpoints
Recovery rate of the mitral isthmus line
Time frame: beyond 3 months after the ablation procedure.
Long-term primary efficacy endpoints
2 secondary outcomes
Procedural characteristics
Time frame: Periprocedural period
Hospitalization costs
Time frame: Periprocedural period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcatheter and OTW in people with Atrial Fibrillation and Atrial Flutter, run by Shanghai Chest Hospital at 5 sites 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 2 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
Contact Xu Liu, MD (+8618101817225, drliuxu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute rate of mitral isthmus block (time frame: During catheter ablation procedures). The study lists 3 primary outcomes in all. 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 14 Jun 2024.