Atrial FibrillationNCT05989321
A New Approach for Catheter Ablation of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
This is a retrospective cohort study of radiofrequency ablation for the treatment atrial fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the investigators propose a hypothesis regarding the underlying electrophysiological mechanism of AF, as well as a novel approach for catheter… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI alone and PVI + SPs ablation
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 15 Jul 2022
- 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: These cases are from a university hospital
Who may be able to join
- patients with underwent the first catheter ablation for symptomatic AF
Who cannot join
- patients with more than one missing follow-up would be excluded
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
About this study
Official title: A New Approach for Catheter Ablation of Atrial Fibrillation: a Retrospective Cohort Study
This is a retrospective cohort study of radiofrequency ablation for the treatment atrial fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the investigators propose a hypothesis regarding the underlying electrophysiological mechanism of AF, as well as a novel approach for catheter ablation of AF.
Read the detailed description
The investigators propose a new electrophysiological mechanism for AF: the superposition hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort study to determine if superposition potentials (SP) can identify the critical regions where AF is sustained and if ablating SPs can improves the long-term efficacy.
The study consecutively collected patients with underwent the first catheter ablation for symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF (lasting <7 days), persistent AF (lasting >7 days and <1 year without electrical cardioversion) and long-term persistent AF (lasting >1 year), aged between 18 and 80 years old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. The eligible patients were divided into two groups: the pulmonary vein isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive clinical history and procedural data of patients were collected from electronic medical records.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI alone, PVI + SPs ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI aloneProcedure or surgery
pulmonary vein isolation
PVI + SPs ablationProcedure or surgery
pulmonary vein isolation + SPs ablation
| Study group | Role | What they receive |
|---|---|---|
| PVI alone group | Patients who undergo PVI alone using ThermoCool SmartTouch catheter. Receives: Procedure: PVI alone | |
| PVI + SPs ablation group | Patients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter. Receives: Procedure: PVI + SPs ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from AF within 12 months
AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. AF recurrence was defined as the occurrence of AF lasting at least 30 seconds after the 3-month blanking period.
Measured: 12 months
Secondary outcomes (1)
the acute termination of AF during the procedure
Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mingli Zhou, The Second Affiliated Hospital of Kunming Medical University
- Investigators
- Mingli Zhou, M.D., Principal investigator, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989321
- Sponsor's protocol ID
- IIT-2023-0052-XXG-004
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach for Catheter Ablation of Atrial Fibrillation: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05989321
- Acronym / sponsor ID
- IIT-2023-0052-XXG-004
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 14 Aug 2023 (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 is a retrospective cohort study of radiofrequency ablation for the treatment atrial fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the investigators propose a hypothesis regarding the underlying electrophysiological mechanism of AF, as well as a novel approach for catheter ablation of AF.
Detailed description
The investigators propose a new electrophysiological mechanism for AF: the superposition hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort study to determine if superposition potentials (SP) can identify the critical regions where AF is sustained and if ablating SPs can improves the long-term efficacy.
The study consecutively collected patients with underwent the first catheter ablation for symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF (lasting <7 days), persistent AF (lasting >7 days and <1 year without electrical cardioversion) and long-term persistent AF (lasting >1 year), aged between 18 and 80 years old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. The eligible patients were divided into two groups: the pulmonary vein isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive clinical history and procedural data of patients were collected from electronic medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI alone group | – | Procedure: PVI alonePatients who undergo PVI alone using ThermoCool SmartTouch catheter. |
| PVI + SPs ablation group | – | Procedure: PVI + SPs ablationPatients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These cases are from a university hospital
Key inclusion criteria (1 listed)
- patients with underwent the first catheter ablation for symptomatic AF
Key exclusion criteria (1 listed)
- patients with more than one missing follow-up would be excluded
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 |
|---|---|---|
| PVI alonepulmonary vein isolation | Procedure or surgery | PVI alone group |
| PVI + SPs ablationpulmonary vein isolation + SPs ablation | Procedure or surgery | PVI + SPs ablation group |
Primary outcome
freedom from AF within 12 months
Time frame: 12 months
AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. AF recurrence was defined as the occurrence of AF lasting at least 30 seconds after the 3-month blanking period.
1 secondary outcome
the acute termination of AF during the procedure
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 32860505Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Mingli Zhou, M.D. principal investigator
The Second Affiliated Hospital of Kunming Medical University
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 Atrial Fibrillation, run by The Second Affiliated Hospital of Kunming Medical 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom from AF within 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05989321, which also lists 1 linked publication.
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 Aug 2023.