Atrial FibrillationCAMERA-PilotNCT05846412
Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation
A study testing Catheter Ablation and M-TEER in people with Atrial Fibrillation and Mitral Regurgitation Functional, run by University of Luebeck.
Trial summary
The objective of the CAMERA-Pilot trial is to generate a hypothesis for a proper randomized controlled clinical endpoint trial to show the noninferiority of restoration and maintenance of sinus rhythm (via catheter ablation [CA] of AF) vs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Mitral Regurgitation Functional
- What is being tested?
- Catheter Ablation and M-TEER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 20 Feb 2026
- Phase
- Interventional
- 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
Who may be able to join
- Symptomatic ventricular FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to cardiomyopathy of either ischemic or non-ischemic etiology (LVEF 30-49%), concomitant with AF
- Symptomatic atrial FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to AF, with normal (≥50%) LVEF
- LV end-systolic diameter ≤70 mm
- Documented history of paroxysmal AF (PAF) or persistent AF for maximally 2 years
- Subject has been adequately treated medically for at least 4 weeks per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation and heart failure
- NYHA functional class II, III or ambulatory IV
- Local heart team has determined that MV surgery is not indicated as a treatment option or will be high risk
- Age 18-80 years
Who cannot join
- Untreated clinically significant coronary artery disease requiring revascularization
- CABG, PCI or TAVR within prior 30 days
- Aortic or tricuspid valve disease (tricuspid regurgitation ≥3+) requiring surgery or transcatheter intervention
- Cerebrovascular accident within prior 30 days
- Severe symptomatic carotid stenosis (>70% by ultrasound)
- Carotid surgery or stenting within prior 30 days
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- NYHA functional class IV requiring in-hospital care
- Implant of CRT or CRT-D within the last 30 days
- Transseptal puncture anatomically not feasible
- Leaflet anatomy which may preclude MitraClip/PASCAL implantation, proper MitraClip/PASCAL positioning on the leaflets, or sufficient reduction in mitral regurgitation by the MitraClip/PASCAL device.
- Current pregnancy or planned pregnancy within next 12 months
About this study
Official title: Catheter Ablation or Percutaneous Mitral Valve Repair to Treat Essential (Moderate/Severe) Functional Mitral Regurgitation in Patients With Atrial Fibrillation - a Pilot Trial
The objective of the CAMERA-Pilot trial is to generate a hypothesis for a proper randomized controlled clinical endpoint trial to show the noninferiority of restoration and maintenance of sinus rhythm (via catheter ablation [CA] of AF) vs. mitral transcatheter edge-to-edge repair (M-TEER) in patients with AF and concomitant FMR. Patients will be stratified into ventricular FMR with atrial component and atrial FMR.
Read the detailed description
Rhythm Control by Catheter Ablation: Patients randomized to rhythm control with CA will undergo CA of AF. The index procedure will comprise pulmonary vein isolation (PVI) using either the cryoballoon or radiofrequency (RF) current or pulsed field ablation at the discretion of the investigator. Additional atrial substrate modification may be performed at the discretion of the investigator.
The objective of rhythm control is to restore sinus rhythm by CA and to maintain sinus rhythm during the 12-month follow-up period. In case of AF recurrence during follow-up, sinus rhythm must be restored as soon as possible, either by adding or changing AADs, electrical cardioversion, or repeat CA.
No attempt will be made to reduce FMR by interventional means. Medical treatment of FMR will follow current guidelines.
M-TEER (Control): Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity. The intervention will be considered successful if FMR is graded 2+ (moderate) or less by an echocardiography core laboratory in accordance with the 2017 Guidelines of the American Society of Echocardiography and specific guidelines on valvular regurgitation after percutaneous valve repair or replacement.
No attempt will be made to restore sinus rhythm, except for patients who remain symptomatic due to AF during follow-up. Medical treatment of AF will follow current guidelines.
- Being tested
- Catheter Ablation and M-TEER
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation and M-TEEROther
Already included in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm Control by Catheter Ablation: | Experimental | Patients randomized to rhythm control with CA will undergo CA of AF. Receives: Other: Catheter Ablation and M-TEER |
| M-TEER (Control): | Active comparator | Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity. Receives: Other: Catheter Ablation and M-TEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMR grade ≤2+ (moderate or less) at 1 year
The FMR grade will be assessed with transesophageal echocardiography
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Karl-Heinz Kuck (MD), University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846412
- Sponsor's protocol ID
- 12-2022
- Acronym
- CAMERA-Pilot
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation or Percutaneous Mitral Valve Repair to Treat Essential (Moderate/Severe) Functional Mitral Regurgitation in Patients With Atrial Fibrillation - a Pilot Trial
- ClinicalTrials.gov ID
- NCT05846412
- Acronym / sponsor ID
- CAMERA-Pilot / 12-2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 May 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.
The objective of the CAMERA-Pilot trial is to generate a hypothesis for a proper randomized controlled clinical endpoint trial to show the noninferiority of restoration and maintenance of sinus rhythm (via catheter ablation [CA] of AF) vs. mitral transcatheter edge-to-edge repair (M-TEER) in patients with AF and concomitant FMR. Patients will be stratified into ventricular FMR with atrial component and atrial FMR.
Detailed description
Rhythm Control by Catheter Ablation: Patients randomized to rhythm control with CA will undergo CA of AF. The index procedure will comprise pulmonary vein isolation (PVI) using either the cryoballoon or radiofrequency (RF) current or pulsed field ablation at the discretion of the investigator. Additional atrial substrate modification may be performed at the discretion of the investigator.
The objective of rhythm control is to restore sinus rhythm by CA and to maintain sinus rhythm during the 12-month follow-up period. In case of AF recurrence during follow-up, sinus rhythm must be restored as soon as possible, either by adding or changing AADs, electrical cardioversion, or repeat CA.
No attempt will be made to reduce FMR by interventional means. Medical treatment of FMR will follow current guidelines.
M-TEER (Control): Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity. The intervention will be considered successful if FMR is graded 2+ (moderate) or less by an echocardiography core laboratory in accordance with the 2017 Guidelines of the American Society of Echocardiography and specific guidelines on valvular regurgitation after percutaneous valve repair or replacement.
No attempt will be made to restore sinus rhythm, except for patients who remain symptomatic due to AF during follow-up. Medical treatment of AF will follow current guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm Control by Catheter Ablation: | Experimental | Other: Catheter Ablation and M-TEERPatients randomized to rhythm control with CA will undergo CA of AF. |
| M-TEER (Control): | Active comparator | Other: Catheter Ablation and M-TEERPatients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic ventricular FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to cardiomyopathy of either ischemic or non-ischemic etiology (LVEF 30-49%), concomitant with AF
- Symptomatic atrial FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to AF, with normal (≥50%) LVEF
- LV end-systolic diameter ≤70 mm
- Documented history of paroxysmal AF (PAF) or persistent AF for maximally 2 years
- Subject has been adequately treated medically for at least 4 weeks per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation and heart failure
Key exclusion criteria (11 listed)
- Untreated clinically significant coronary artery disease requiring revascularization
- CABG, PCI or TAVR within prior 30 days
- Aortic or tricuspid valve disease (tricuspid regurgitation ≥3+) requiring surgery or transcatheter intervention
- Cerebrovascular accident within prior 30 days
- Severe symptomatic carotid stenosis (>70% by ultrasound)
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 Ablation and M-TEERAlready included in arm descriptions. | Other | M-TEER (Control):, Rhythm Control by Catheter Ablation: |
Primary outcome
FMR grade ≤2+ (moderate or less) at 1 year
Time frame: 24 Month
The FMR grade will be assessed with transesophageal echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation and M-TEER in people with Atrial Fibrillation and Mitral Regurgitation Functional, run by University of Luebeck.
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 8 inclusion and 11 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
FMR grade ≤2+ (moderate or less) at 1 year (time frame: 24 Month). 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 6 May 2023.