Catheter AblationNCT02846922
Catheter Ablation and Rate Control of Atrial Fibrillation in Patients With Heart Failure
An observational study of Catheter Ablation and Rate Control, run by Nanjing Medical University at 1 site in China.
Trial summary
To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Ablation, Rate Control, Heart Failure
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients coexisted with heart failure and atrial fibrillation
Who may be able to join
- age>18 years
- documented atrial fibrillation
- New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction <50%
Who cannot join
- heart failure that had a suspected reversible cause
- previous ablation
- any contraindication to catheter ablation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Catheter Ablation Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure: A Multicenter Study
To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.
Read the detailed description
All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.
- Conditions
- Catheter Ablation, Rate Control, Heart Failure, Atrial Fibrillation
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| catheter ablation group | atrial fibrillation patients with heart failure who received catheter ablation for rhythm control | |
| rate control group | atrial fibrillation patients with heart failure who received pharmacological approaches for rate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons
Measured: up to 3 years
Secondary outcomes (3)
all-cause mortality
Measured: up to 3 years
stroke
stroke must be certified by CT scan
Measured: up to 3 years
unplanned hospitalization due to cardiovascular reasons
Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of heart failure and ventricular arrhythmias
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter AblationStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- Retrospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Geng, Nanjing Medical University
- Investigators
- Jin Geng, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolBingjian Wang, MD, Study chair, Huai'an First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846922
- Sponsor's protocol ID
- 20160020
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2016
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure: A Multicenter Study
- ClinicalTrials.gov ID
- NCT02846922
- Acronym / sponsor ID
- 20160020
- Conditions
- Catheter Ablation, Rate Control, Heart Failure, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.
Detailed description
All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| catheter ablation group | – | –atrial fibrillation patients with heart failure who received catheter ablation for rhythm control |
| rate control group | – | –atrial fibrillation patients with heart failure who received pharmacological approaches for rate control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coexisted with heart failure and atrial fibrillation
Key inclusion criteria (3 listed)
- age>18 years
- documented atrial fibrillation
- New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction <50%
Key exclusion criteria (3 listed)
- heart failure that had a suspected reversible cause
- previous ablation
- any contraindication to catheter ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac events
Time frame: up to 3 years
composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons
3 secondary outcomes
all-cause mortality
Time frame: up to 3 years
stroke
Time frame: up to 3 years
unplanned hospitalization due to cardiovascular reasons
Time frame: up to 3 years
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 13 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Catheter Ablation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
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.
Jin Geng, MD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Bingjian Wang, MD study chair
Huai'an First People's Hospital
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 Catheter Ablation and Rate Control, run by Nanjing 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 3 inclusion and 3 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 13 Jul 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?
Major adverse cardiac events (time frame: up to 3 years). 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 13 Jul 2023.