Persistent Atrial FibrillationNCT05826665
Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
An observational study of Persistent Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 4 sites in United States.
Trial summary
STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining Atrial Fibrillation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Persistent AF ablation assisted with the STAR Apollo Mapping System
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Oct 2023to 31 Jul 2025
- 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: Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post PVI, will be considered for this study.
Who may be able to join
- Indication for ablation of persistent AF
- Age >18 years
- Persistent AF >7 days and total continuous duration <2 years
- Patients have previously undergone pulmonary vein isolation, using any technique and have had AF recurrence.
- Patients have limited additional ablation at their first procedure (e.g. right atrial flutter line).
Who cannot join
- Patients with previous ablation in more than one region of the left atrium in addition to the pulmonary veins.
- Patients with longstanding persistent AF (continuous duration >2 years) or significant substrate (mitral valve disease, scarring, very dilated atria >50mm).
- Creatinine clearance estimated glomerular filtration rate (eGFR) <30mls/min
- Contraindication to anticoagulation
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Not yet recruiting
St.Bernards Medical Center
Jonesboro, Arkansas, 72401
Devi Nair, MD
Kayla Rubino, 870-9356-729, krubino@dnairresearch.com
- Not yet recruiting
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
Dhanunjaya Lakkireddy, MD, 913-449-1297, dlakkireddy@gmail.com
- Recruiting
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Donita Atkins
- Recruiting
Sarasota Medical Center
Sarasota, Florida, 34239
Dilip Matthew, MD
Colleen Lindner, colleen-lindner@smh.com
About this study
STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining Atrial Fibrillation (AF). The STAR Apollo Mapping System system allows clinicians, after treating the Pulmonary Veins (PV), to collect data from the atria during clinical AF procedures using standard FDA cleared catheters and devices. This study aims to examine the impact of the STAR Apollo Mapping System on procedural and acute outcomes in a multicenter observational study.
Read the detailed description
Atrial fibrillation (AF) is the most common heart rhythm abnormality. It affects 1 in 100 people. It can cause unpleasant symptoms of palpitation, shortness of breath and in some can cause heart failure or stroke. AF is triggered by abnormal electrical signals originating both in the pulmonary veins (PV), the veins that drain blood from the lungs into the heart, and in the rest of the left atrium, the heart chamber that the PVs drain into. AF can be successfully treated by a procedure called catheter ablation. This involves passing a wire up the vein at the top of the leg and delivering radiofrequency energy to the atrial tissue. This renders that tissue electrically inert. For many years this procedure has been guided by 3D cardiac mapping systems capable of showing the position of the catheters in the heart and recording their electrical signals. By doing a series of radiofrequency treatments around the mouth of the PVs it is possible to electrically isolate them so that PV signals cannot start or sustain AF. This leaves the left atrial signals untreated and limits the success of the procedure to 50%. To date clinicians have tried numerous ways to identify these remaining left atrial signals, but so far, their efforts have not improved the outcomes of ablation over just isolating the PVs alone (50% success rate). STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining AF. The STAR Apollo Mapping System system allows clinicians, after treating the PVs, to collect data from the atria during clinical AF procedures using standard FDA cleared catheters and devices. This study aims to examine the impact of the STAR Apollo Mapping System on procedural and acute outcomes in a multicenter observational study.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Persistent AF ablation assisted with the STAR Apollo Mapping System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persistent AF ablation assisted with the STAR Apollo Mapping SystemOther
This exploratory hypothesis generating data set will be collected during standard AF ablation procedures using FDA cleared technologies as described in their Instructions for Use (IFU). No randomization or experimental protocols will be used during this study, and all follow up will be performed as per the center's standard of care(SOC).
| Study group | Role | What they receive |
|---|---|---|
| STAR Apollo Mapping System Group | Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post Pulmonary Vein Isolation (PVI), will be considered for this study. Receives: Other: Persistent AF ablation assisted with the STAR Apollo Mapping System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation
The primary objective for the study is to determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation. These include procedure duration and the number of radiofrequency (RF) lesions applied post PVI.
Measured: 12 Months
Secondary outcomes (1)
To observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data
The secondary objective is to observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data and the physician's treatment plan that may influence outcomes.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start2 Oct 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
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 Persistent 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute, St. Bernards Medical Center, Sarasota Medical Center
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826665
- Sponsor's protocol ID
- KCHRRF_Star Apollo_0018
- Status last verified
- Oct 2024
- First submitted
- 12 Apr 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kabra R, McKillop M, Vora A, Oza S, Nair DG, Mathew D, Darden D, Lakkireddy DR; STAR Apollo Study Investigators. Map-guided redo ablation for recurrent persistent atrial fibrillation after prior pulmonary vein isolation: Procedural feasibility, safety, and 12-month rhythm outcomes from a prospective multicenter study (NCT05826665). Heart Rhythm. 2026 Sep 20:S1547-5271(26)02767-0. doi: 10.1016/j.hrthm.2026.09.004. Online ahead of print.
PubMed 42764111
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
- ClinicalTrials.gov ID
- NCT05826665
- Acronym / sponsor ID
- KCHRRF_Star Apollo_0018
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute, St. Bernards Medical Center, Sarasota Medical Center
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 24 Apr 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.
STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining Atrial Fibrillation (AF). The STAR Apollo Mapping System system allows clinicians, after treating the Pulmonary Veins (PV), to collect data from the atria during clinical AF procedures using standard FDA cleared catheters and devices. This study aims to examine the impact of the STAR Apollo Mapping System on procedural and acute outcomes in a multicenter observational study.
Detailed description
Atrial fibrillation (AF) is the most common heart rhythm abnormality. It affects 1 in 100 people. It can cause unpleasant symptoms of palpitation, shortness of breath and in some can cause heart failure or stroke. AF is triggered by abnormal electrical signals originating both in the pulmonary veins (PV), the veins that drain blood from the lungs into the heart, and in the rest of the left atrium, the heart chamber that the PVs drain into. AF can be successfully treated by a procedure called catheter ablation. This involves passing a wire up the vein at the top of the leg and delivering radiofrequency energy to the atrial tissue. This renders that tissue electrically inert. For many years this procedure has been guided by 3D cardiac mapping systems capable of showing the position of the catheters in the heart and recording their electrical signals. By doing a series of radiofrequency treatments around the mouth of the PVs it is possible to electrically isolate them so that PV signals cannot start or sustain AF. This leaves the left atrial signals untreated and limits the success of the procedure to 50%. To date clinicians have tried numerous ways to identify these remaining left atrial signals, but so far, their efforts have not improved the outcomes of ablation over just isolating the PVs alone (50% success rate). STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining AF. The STAR Apollo Mapping System system allows clinicians, after treating the PVs, to collect data from the atria during clinical AF procedures using standard FDA cleared catheters and devices. This study aims to examine the impact of the STAR Apollo Mapping System on procedural and acute outcomes in a multicenter observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STAR Apollo Mapping System Group | – | Other: Persistent AF ablation assisted with the STAR Apollo Mapping SystemPatients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post Pulmonary Vein Isolation (PVI), will be considered for this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred for persistent AF catheter ablation, who have already had AF recurrence post PVI, will be considered for this study.
Key inclusion criteria (5 listed)
- Indication for ablation of persistent AF
- Age >18 years
- Persistent AF >7 days and total continuous duration <2 years
- Patients have previously undergone pulmonary vein isolation, using any technique and have had AF recurrence.
- Patients have limited additional ablation at their first procedure (e.g. right atrial flutter line).
Key exclusion criteria (4 listed)
- Patients with previous ablation in more than one region of the left atrium in addition to the pulmonary veins.
- Patients with longstanding persistent AF (continuous duration >2 years) or significant substrate (mitral valve disease, scarring, very dilated atria >50mm).
- Creatinine clearance estimated glomerular filtration rate (eGFR) <30mls/min
- Contraindication to anticoagulation
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 |
|---|---|---|
| Persistent AF ablation assisted with the STAR Apollo Mapping SystemThis exploratory hypothesis generating data set will be collected during standard AF ablation procedures using FDA cleared technologies as described in their Instructions for Use (IFU). No randomization or experimental protocols will be used during this study, and all follow up will be performed as per the center's standard of care(SOC). | Other | STAR Apollo Mapping System Group |
Primary outcome
To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation
Time frame: 12 Months
The primary objective for the study is to determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation. These include procedure duration and the number of radiofrequency (RF) lesions applied post PVI.
1 secondary outcome
To observe the acute procedural outcomes and the features of the STAR Apollo Mapping System data
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 42764111Kabra R, McKillop M, Vora A, Oza S, Nair DG, Mathew D, Darden D, Lakkireddy DR; STAR Apollo Study Investigators. Map-guided redo ablation for recurrent persistent atrial fibrillation after prior pulmonary vein isolation: Procedural feasibility, safety, and 12-month rhythm outcomes from a prospective multicenter study (NCT05826665). Heart Rhythm. 2026 Sep 20:S1547-5271(26)02767-0. doi: 10.1016/j.hrthm.2026.09.004. Online ahead of print.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 4 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the impact of STAR Apollo Mapping System on the procedural parameters of persistent AF ablation (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 NCT05826665, 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 16 Oct 2024.