Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac SurgeryNCT03613831
Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)
An observational study of Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery, run by Boston Scientific Corporation at 1 site in China.
Trial summary
This study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
- What is being tested?
- patient who used Rhythmia system and Orion catheter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Feb 2023
- 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: An arbitrary sample size of 100 should be enough for this registry study which may cover the focal, macro-reentry, micro-reentry and other types of atrial tachycardia. Assuming that the one-year recurrence rate post complex atrial tachycardia ablation is 30%, the 95% confidence interval of 100 samples shall be 21.2-40.0% (binomial distribution exact method). As per the current actual situation in China, it is predicted that 70-80 cases may be included for the atrial tachycardia post atrial fibrillation ablation, while 20-30 cases may be included for post cardiac surgery.
Who may be able to join
- Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment;
- Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
- Subject is age 18 or above;
- Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail.
Who cannot join
- Subject with atrial fibrillation only;
- Subject is enrolled in any other concurrent study that might interfere with this study;
- Women of childbearing potential who are or might be pregnant at the time of this study
Trial locations and contacts
1 site in 1 country.
About this study
This study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System.
- Conditions
- Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
- Being tested
- patient who used Rhythmia system and Orion catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient who used Rhythmia system and Orion catheterDevice
suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
target patient's type
Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: The sponsor has decided to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613831
- Sponsor's protocol ID
- PCR02
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)
- ClinicalTrials.gov ID
- NCT03613831
- Acronym / sponsor ID
- PCR02
- Conditions
- Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor has decided to stop the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 3 Aug 2018 (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 an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An arbitrary sample size of 100 should be enough for this registry study which may cover the focal, macro-reentry, micro-reentry and other types of atrial tachycardia. Assuming that the one-year recurrence rate post complex atrial tachycardia ablation is 30%, the 95% confidence interval of 100 samples shall be 21.2-40.0% (binomial distribution exact method). As per the current actual situation in China, it is predicted that 70-80 cases may be included for the atrial tachycardia post atrial fibrillation ablation, while 20-30 cases may be included for post cardiac surgery.
Key inclusion criteria (4 listed)
- Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment;
- Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
- Subject is age 18 or above;
- Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail.
Key exclusion criteria (3 listed)
- Subject with atrial fibrillation only;
- Subject is enrolled in any other concurrent study that might interfere with this study;
- Women of childbearing potential who are or might be pregnant at the time of this study
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 |
|---|---|---|
| patient who used Rhythmia system and Orion cathetersuitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion | Device | – |
Primary outcome
target patient's type
Time frame: 1 year
Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery, run by Boston Scientific Corporation 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 4 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: withdrawn, as of the sponsor's last update on 1 Sep 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
target patient's type (time frame: 1 year). 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 1 Sep 2020.