Cardiovascular DiseasesNCT05364866
CAB Versus Medical Therapy in Patients With AF and HF With Different EF Categories
An observational study of Cardiovascular Diseases, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Antiarrhythmic drug Therapy and cryoballoon ablation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
Who may be able to join
- Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
- At least 18 years old and not older than 80 years old.
- Able and willing to give informed consent.
Who cannot join
- History of AF treatment with class I or III AAD, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
- Previous left atrial ablation.
- Previous cardiac surgery including prosthetic valves.
- Permanent pacemaker or defibrillator implant.
- Second degree type II or third degree AV-block or a pattern of left/right bundle branch block.
- History of previous myocardial infarction or percutaneous intervention during the last 3 months.
Show all 31Show fewer
- Any history of previous transient ischemic attack, prolonged reversible ischemic neurological deficit, and/or stroke.
- Known intracardiac thrombus formation.
- Pulmonary vein stent.
- Known cryoglobulinaemia.
- Active systemic infection.
- Hypertrophic cardiomyopathy.
- Life expectancy is ≤1 year.
- Reversible cause of atrial fibrillation (eg, hyperthyroidism or alcoholism).
- Abnormal long or short QT intervals, signs of Brugada syndrome, known family history of inherited ion channel disease, and/or arrhythmogenic right ventricular dysplasia.
- Chronic obstructive pulmonary disease with detected pulmonary hypertension and/or any other evidence of significant lung disease.
- Contraindication for oral anticoagulation.
- Pregnant women or woman of childbearing potential with inadequate birth control.
- Women who are breastfeeding.
- Any significant congenital heart defect corrected or not corrected; however, patent foramen ovale is allowed.
- Thrombocytosis (platelet count > 600,000/μL) or thrombocytopenia (platelet count < 100,000/μL).
- Untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Renal dysfunction with glomerular filtration rate < 60 mL/min.
- Unstable angina pectoris.
- Symptomatic carotid stenosis.
- Myxoma based on laboratory abnormalities.
- Sarcoidosis.
- Unwilling to unable to comply with the study procedure and follow-up schedule due to any disease condition.
- Legal incapacity or evidence that the patient cannot understand the purpose and risks of the study, including inability to comply fully with study procedures and follow-up.
- Employed by Medtronic, or the department of an investigator, or close-familial relative of an investigator.
- Enrolled or planning to participate in a potentially confounding drug or device trial during this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
Qi Lu, Dr., 13962989292, luqint@sina.com
About this study
Official title: Cryoballoon Ablation Versus Medical Therapy in Patients With Atrial Fibrillation and Heart Failure With Different Ejection Fraction Categories
This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.
Read the detailed description
Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.
- Conditions
- Cardiovascular Diseases
- Being tested
- Antiarrhythmic drug Therapy, cryoballoon ablation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drug TherapyDrug
Also called Class I or III antiarrhythmic drug
Propafenone, Sotalol and Amiodarone
cryoballoon ablationDevice
Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters including 23mm and 28mm.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment group | Using class I or class III AAD to maintain sinus rhythm Receives: Drug: Antiarrhythmic drug Therapy | |
| Cryoballoon ablation group | Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm) Receives: Device: cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success at one year
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Measured: one year
Rate of adverse events
Rate of complications and adverse events occurred during cryoballoon ablation and postoperative follow-up, including all-cause mortality, rehospitalisation for HF, and the composite event of all-cause mortality or HF hospitalisation
Measured: one year
Secondary outcomes (3)
Arrhythmia recurrence during blanking period
atrial tachycardia recurrence
Measured: 3 months
Quality of life changes at 12 months measured by 12-Item Short Form Survey (SF-12)
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12) with the values ranging from 12 - 47 (higher scores mean a worse outcome)
Measured: one year
Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT) with the values ranging from 20 - 140 (higher scores mean a worse outcome)
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 posted6 May 2022
- Study start1 May 2022
- Primary completion31 Dec 2023 (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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364866
- Sponsor's protocol ID
- 2022-K039-01
- Status last verified
- Jun 2023
- First submitted
- 6 Apr 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Ablation Versus Medical Therapy in Patients With Atrial Fibrillation and Heart Failure With Different Ejection Fraction Categories
- ClinicalTrials.gov ID
- NCT05364866
- Acronym / sponsor ID
- 2022-K039-01
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 May 2022 (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 is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.
Detailed description
Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment group | – | Drug: Antiarrhythmic drug TherapyUsing class I or class III AAD to maintain sinus rhythm |
| Cryoballoon ablation group | – | Device: cryoballoon ablationPulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
Key inclusion criteria (3 listed)
- Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
- At least 18 years old and not older than 80 years old.
- Able and willing to give informed consent.
Key exclusion criteria (31 listed)
- History of AF treatment with class I or III AAD, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
- Previous left atrial ablation.
- Previous cardiac surgery including prosthetic valves.
- Permanent pacemaker or defibrillator implant.
- Second degree type II or third degree AV-block or a pattern of left/right bundle branch block.
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 |
|---|---|---|
| Antiarrhythmic drug TherapyAlso: Class I or III antiarrhythmic drugPropafenone, Sotalol and Amiodarone | Drug | Medical treatment group |
| cryoballoon ablationMedtronic Arctic Front Advance™ Cardiac CryoAblation Catheters including 23mm and 28mm. | Device | Cryoballoon ablation group |
Primary outcome
Treatment success at one year
Time frame: one year
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Rate of adverse events
Time frame: one year
Rate of complications and adverse events occurred during cryoballoon ablation and postoperative follow-up, including all-cause mortality, rehospitalisation for HF, and the composite event of all-cause mortality or HF hospitalisation
3 secondary outcomes
Arrhythmia recurrence during blanking period
Time frame: 3 months
Quality of life changes at 12 months measured by 12-Item Short Form Survey (SF-12)
Time frame: one year
Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Affiliated Hospital of Nantong University 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 3 inclusion and 31 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 15 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Lu, MD (+8613962989292, luqint@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success at one year (time frame: one year). The study lists 2 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 15 Jun 2023.