Atrial Flutter TypicalPVI-AFL-HFNCT06817447
Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure
A study testing Pulmonary vein isolation plus cavo-tricuspid isthmus ablation and Cavo-tricuspid isthmus ablation in people with Atrial Flutter Typical and Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Flutter Typical, Heart Failure
- What is being tested?
- Pulmonary vein isolation plus cavo-tricuspid isthmus ablation and Cavo-tricuspid isthmus ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years
- Typical AFL referring for ablation
- No prior history of AF
- Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) >125 pg/ml in sinus rhythm or >365 pg/ml in AFL
- Optimized guideline-directed medical therapy for HF for at least one month
- A minimum of anticoagulation for three weeks
- Sign informed consent
Who cannot join
- Any AF episodes documented during 48-hour Holter monitoring
- Presence of left atrial thrombus
- HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
- Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
- Untreated hypothyroidism or hyperthyroidism
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- Dialysis-dependent terminal renal failure
- Life expectancy <12 months due to non-cardiovascular causes.
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- Female under pregnancy or breast-feeding
- Involved in other studies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study
This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.
- Conditions
- Atrial Flutter Typical, Heart Failure
- Being tested
- Pulmonary vein isolation plus cavo-tricuspid isthmus ablation, Cavo-tricuspid isthmus ablation
- Keywords
- atrial flutter, Heart failure, Pulmonary vein isolation
- Medical subject headings
- Heart Failure, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation plus cavo-tricuspid isthmus ablationProcedure or surgery
For those who are randomized to CTI+CPVI Arm, additional CPVI should be performed after finishing CTI ablation. CPVI could be performed using open-irrigated contact-force catheter, cryoballoon catheter or pulse-field ablation catheter. The endpoint is defined as both entrance and exit block in the pulmonary veins.
Cavo-tricuspid isthmus ablationProcedure or surgery
In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl.
CTI ablation should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. Radiofrequency should be delivered at 30-50 W with a contact-force between 5-30 g in a point-by-point fashion until the CTI line is completed. Touch-up radiofrequency should be performed as needed. The endpoint of ablation is termination of AFL, if present, and the demonstration of bidirectional block across the CTI by using differential pacing.
| Study group | Role | What they receive |
|---|---|---|
| CTI-alone arm | Active comparator | Not described Receives: Procedure: Cavo-tricuspid isthmus ablation |
| CTI+CPVI Arm | Experimental | Not described Receives: Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Secondary outcomes (11)
Time to cardiovascular death
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to hospitalization or urgent visits for heart failure
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to hospitalization for heart failure
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to urgent visits for heart failure
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to all-cause death
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to atrial fibrillation recurrence
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to change of diuretics
Measured: From randomization until completion of the planned follow-up, assessed up to 48 months
Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: One-year
Change in 6-minute walk test at one-year
Measured: One-year
Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year
Measured: One-year
Change in New York Heart Association (NYHA) class at one-year
NYHA class is a widely used system for assessing the functional status and severity of heart failure symptoms in patients, with NYHA class IV being the worst.
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Flutter TypicalStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minglong Chen, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817447
- Sponsor's protocol ID
- 2025-SR-026
- Acronym
- PVI-AFL-HF
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2025
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06817447
- Acronym / sponsor ID
- PVI-AFL-HF / 2025-SR-026
- Conditions
- Atrial Flutter Typical, Heart Failure
- Keywords
- atrial flutter, Heart failure, Pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 10 Feb 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 study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTI-alone arm | Active comparator | Procedure: Cavo-tricuspid isthmus ablation |
| CTI+CPVI Arm | Experimental | Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 80 years
- Typical AFL referring for ablation
- No prior history of AF
- Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) >125 pg/ml in sinus rhythm or >365 pg/ml in AFL
- Optimized guideline-directed medical therapy for HF for at least one month
Key exclusion criteria (11 listed)
- Any AF episodes documented during 48-hour Holter monitoring
- Presence of left atrial thrombus
- HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
- Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
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 |
|---|---|---|
| Pulmonary vein isolation plus cavo-tricuspid isthmus ablationFor those who are randomized to CTI+CPVI Arm, additional CPVI should be performed after finishing CTI ablation. CPVI could be performed using open-irrigated contact-force catheter, cryoballoon catheter or pulse-field ablation catheter. The endpoint is defined as both entrance and exit block in the pulmonary veins. | Procedure or surgery | CTI+CPVI Arm |
| Cavo-tricuspid isthmus ablationIn periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. CTI ablation should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. Radiofrequency should be delivered at 30-50 W with a contact-force between 5-30 g in a point-by-point fashion until the CTI line is completed. Touch-up radiofrequency should be performed as needed. The endpoint of ablation is termination of AFL, if present, and the demonstration of bidirectional block across the CTI by using differential pacing. | Procedure or surgery | CTI-alone arm |
Primary outcome
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
11 secondary outcomes
Time to cardiovascular death
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to hospitalization or urgent visits for heart failure
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to hospitalization for heart failure
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to urgent visits for heart failure
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to all-cause death
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to atrial fibrillation recurrence
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Time to change of diuretics
Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months
Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year
Time frame: One-year
Change in 6-minute walk test at one-year
Time frame: One-year
Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year
Time frame: One-year
Change in New York Heart Association (NYHA) class at one-year
Time frame: One-year
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 10 Feb 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation plus cavo-tricuspid isthmus ablation and Cavo-tricuspid isthmus ablation in people with Atrial Flutter Typical and Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Youmei Shen, M.D. (+86-15720801576, symnjmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death (time frame: From randomization until completion of the planned follow-up, assessed up to 48 months). 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 10 Feb 2025.