Arrhythmia, CardiacPhase 4ABLATE-CRTNCT03035227
Catheter Ablation of Arrhythmias to Improve CRT Response
A Phase 4 study testing Catheter Ablation and Anti-Arrhythmics in people with Arrhythmia, Cardiac, run by Kansas City Heart Rhythm Institute at 1 site in United States.
Trial summary
The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arrhythmia, Cardiac
- What is being tested?
- Catheter Ablation and Anti-Arrhythmics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 1 May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Heart failure patients with CRT-D or CRT-P greater than 3 months
- Bi-ventricular pacing less than 94% of the time
- 3 months after CRT-D or CRT-P implantation an EF improvement less than 5%
- Presence of one of the following arrhythmias and eligible for catheter ablation:
- Atrial fibrillation
- Atrial flutter
Show all 9Show fewer
- Supraventricular tachycardia
- Premature ventricular contraction burden greater than 30% in a 24-hour period
- Ventricular tachycardia
Who cannot join
- Estimated survival less than one year
- Patient unable to make scheduled follow up visits at treating center
- Participating in another investigational study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.
- Conditions
- Arrhythmia, Cardiac
- Being tested
- Catheter Ablation, Anti-Arrhythmics
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.
Anti-ArrhythmicsDrug
Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation | Active comparator | Catheter ablation procedure of atrial and/or ventricular arrhythmias. Receives: Procedure: Catheter Ablation |
| Medical Therapy | Active comparator | Medical management using antiarrhythmic drugs per standard of care of treating physician. Receives: Drug: Anti-Arrhythmics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ejection Fraction (EF)
Change in Ejection Fraction (EF)
Measured: 90 Days
Bi-ventricular Pacing Improvement
data not analyzed
Measured: 90 Days
Cardiovascular Mortality
data not analyzed
Measured: 365Days
Secondary outcomes (6)
All-cause Mortality
data was not analyzed
Measured: 365 Days
Hospital Admissions for Heart Failure Exacerbation
data not analyzed
Measured: 365 Days
New York Heart Association (NYHA) Class Change
Measured: 30 Days
Change in 6 Minute Walk Test
data not analyzed
Measured: 30 Days
Change in Quality of Life - SF-36
data not analyzed
Measured: 30 Days
Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
data not analyzed
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: Investigator left Institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arrhythmia, CardiacStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035227
- Sponsor's protocol ID
- STUDY00003861
- Acronym
- ABLATE-CRT
- Status last verified
- Apr 2020
- First submitted
- 25 Jan 2017
- Last updated
- 10 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation of Arrhythmias to Improve CRT Response
- ClinicalTrials.gov ID
- NCT03035227
- Acronym / sponsor ID
- ABLATE-CRT / STUDY00003861
- Conditions
- Arrhythmia, Cardiac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left Institution.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm InstituteUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Posted 10 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | Active comparator | Procedure: Catheter AblationCatheter ablation procedure of atrial and/or ventricular arrhythmias. |
| Medical Therapy | Active comparator | Drug: Anti-ArrhythmicsMedical management using antiarrhythmic drugs per standard of care of treating physician. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Heart failure patients with CRT-D or CRT-P greater than 3 months
- Bi-ventricular pacing less than 94% of the time
- 3 months after CRT-D or CRT-P implantation an EF improvement less than 5%
- Presence of one of the following arrhythmias and eligible for catheter ablation:
- Atrial fibrillation
Key exclusion criteria (3 listed)
- Estimated survival less than one year
- Patient unable to make scheduled follow up visits at treating center
- Participating in another investigational 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 |
|---|---|---|
| Catheter AblationCatheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists. | Procedure or surgery | Catheter Ablation |
| Anti-ArrhythmicsAnti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician. | Drug | Medical Therapy |
Primary outcome
Change in Ejection Fraction (EF)
Time frame: 90 Days
Change in Ejection Fraction (EF)
Bi-ventricular Pacing Improvement
Time frame: 90 Days
data not analyzed
Cardiovascular Mortality
Time frame: 365Days
data not analyzed
6 secondary outcomes
All-cause Mortality
Time frame: 365 Days
Hospital Admissions for Heart Failure Exacerbation
Time frame: 365 Days
New York Heart Association (NYHA) Class Change
Time frame: 30 Days
Change in 6 Minute Walk Test
Time frame: 30 Days
Change in Quality of Life - SF-36
Time frame: 30 Days
Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter Ablation and Anti-Arrhythmics in people with Arrhythmia, Cardiac, run by Kansas City Heart Rhythm Institute at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 10 Sep 2022. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Ejection Fraction (EF) (time frame: 90 Days). The study lists 3 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 10 Sep 2022.