An interventional study of Pulmonary vein isolation plus cavo-tricuspid isthmus ablation and Cavo-tricuspid isthmus ablation in Atrial Flutter Typical and Heart Failure, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 168 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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Exclusion Criteria:
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Cavo-tricuspid isthmus ablation
Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation
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.
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.
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
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
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.
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
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.
Time frame: One-year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →