Coagulation; IntravascularPhase 3COHERENCT01935557
Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
A Phase 3 study testing Continuous heparin infusion and Intermittent heparin infusion in people with Coagulation; Intravascular, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important. Randomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coagulation; Intravascular
- What is being tested?
- Continuous heparin infusion and Intermittent heparin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2015
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Atrial Fibrillation, Radiofrequency catheter ablation scheduled
Who cannot join
- Clinical trial denied
Trial locations and contacts
1 site in 1 country.
About this study
Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important.
Randomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation.
Read the detailed description
Intravenous heparin was used during the procedure to prevent catheter-induced thrombosis.
heparin is administered during the procedure to achieve recommended activation clotting times (ACT) values, typically >300 seconds to prevent thromboemboli during the procedure.
Most of the practitioners was that ACT level should be checked at 30- to 60-minute intervals and then have injected intermittently.
intermittent heparin infusion, concentration is great changed because the heparin has 30minutes half-period.
researchers postulate that a constant therapeutic concentrations would be beneficial to continuous infusion than intermittent infusion.
- Conditions
- Coagulation; Intravascular
- Being tested
- Continuous heparin infusion, Intermittent heparin infusion
- Keywords
- Continuous heparin infusion, Intermittent heparin infusion, during catheter ablation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous heparin infusionDrug
continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
Intermittent heparin infusionDrug
Intermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician.
| Study group | Role | What they receive |
|---|---|---|
| Continuous heparin infusion group | Active comparator | continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural. Receives: Drug: Continuous heparin infusion |
| Intermittent heparin infusion group | Active comparator | Intermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician. Receives: Drug: Intermittent heparin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic ACT retention rate during procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2015
- Study completionDec 2015
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 Coagulation; IntravascularStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- Yong Seog Oh, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935557
- Sponsor's protocol ID
- COHERE
- Acronym
- COHERE
- Status last verified
- Apr 2016
- First submitted
- 1 Sep 2013
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim TS, Kim SH, Kim BK, Kim JY, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Randomized Comparison of Continuous Versus Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2016 Jun;2(3):319-326. doi: 10.1016/j.jacep.2015.11.004. Epub 2015 Dec 9.
PubMed 29766891
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01935557
- Acronym / sponsor ID
- COHERE / COHERE
- Conditions
- Coagulation; Intravascular
- Keywords
- Continuous heparin infusion, Intermittent heparin infusion, during catheter ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Sep 2013 (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.
Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important.
Randomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation.
Detailed description
Intravenous heparin was used during the procedure to prevent catheter-induced thrombosis.
heparin is administered during the procedure to achieve recommended activation clotting times (ACT) values, typically >300 seconds to prevent thromboemboli during the procedure.
Most of the practitioners was that ACT level should be checked at 30- to 60-minute intervals and then have injected intermittently.
intermittent heparin infusion, concentration is great changed because the heparin has 30minutes half-period.
researchers postulate that a constant therapeutic concentrations would be beneficial to continuous infusion than intermittent infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous heparin infusion group | Active comparator | Drug: Continuous heparin infusioncontinuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural. |
| Intermittent heparin infusion group | Active comparator | Drug: Intermittent heparin infusionIntermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Atrial Fibrillation, Radiofrequency catheter ablation scheduled
Key exclusion criteria (1 listed)
- Clinical trial denied
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 |
|---|---|---|
| Continuous heparin infusioncontinuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural. | Drug | Continuous heparin infusion group |
| Intermittent heparin infusionIntermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician. | Drug | Intermittent heparin infusion group |
Primary outcome
therapeutic ACT retention rate during procedure
Time frame: 2 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 14 Apr 2016.
- Derived from this study: PubMed 29766891Kim TS, Kim SH, Kim BK, Kim JY, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Randomized Comparison of Continuous Versus Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2016 Jun;2(3):319-326. doi: 10.1016/j.jacep.2015.11.004. Epub 2015 Dec 9.
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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.
Yong Seog Oh, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous heparin infusion and Intermittent heparin infusion in people with Coagulation; Intravascular, run by Yong Seog Oh at 1 site in South Korea.
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 Apr 2016. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
therapeutic ACT retention rate during procedure (time frame: 2 years). 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 NCT01935557, 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 Apr 2016.