Arrhythmias, CardiacPhase 2NCT03265431

Evaluation of PET/MR in Patients Selected for Ablation Therapy

A Phase 2 study testing 18F-TPP in people with Arrhythmias, Cardiac, run by Massachusetts General Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Arrhythmias, Cardiac
What is being tested?: 18F-TPP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2017to 30 Jun 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 21 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must be ≥21 and ≤80 years of age;
Subjects must provide informed consent prior to study procedures;
Subjects must be ≥21 and ≤80 years of age;
Subjects must provide informed consent prior to study procedures;
History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided catheter ablation for clinical care

Who cannot join

Known structural heart disease (e.g. myocardial infarction);
History of ventricular arrhythmia;
Any contraindication to MRI and/or PET, including:
Subjects with life vest;
Subjects with implanted heart device (e.g. ICD, Pacemaker);
Subjects with metallic fragment or foreign body;

Show all 32Show fewer

Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
Claustrophobia;
Relative or absolute contraindication to Dotarem contrast:
history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate <60 mL/min/1.73m2);
a history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent
Any clinically significant acute or unstable physical or psychological disease, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination
Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
Inability to provide written informed consent;
Arrhythmia Subjects:
Any contraindication to MRI and/or PET, including:
Subjects with life vest;
Subjects with implanted heart device (e.g. ICD, Pacemaker);
Subjects with metallic fragment or foreign body;
Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
Claustrophobia;
Relative or absolute contraindication to Dotarem contrast:
history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate <60 mL/min/1.73m2);
history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;Any clinically significant acute or unstable physical or psychological disease, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination
Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
Inability to provide written informed consent;

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

This study is performed to assess if PET-MR imaging can improve treatment of patients with irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One category of irregular heart rate is called ventricular arrhythmia. It is often seen in patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation does not fix the problem in 100% of patients and some will still have the arrhythmia requiring repeated procedure. The purpose of this study is to find new ways of guiding the doctors performing ablation, hoping to improve the success rate of the procedure.

Conditions: Arrhythmias, Cardiac
Being tested: 18F-TPP
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F-TPPDrug
Also called 18F-BFPET
Imaging with 18-F-TPP (18F-BFPET)

Study groups in NCT03265431
Study group	Role	What they receive
Control	Active comparator	Normal subjects without history of cardiac disease or arrhythmia Receives: Drug: 18F-TPP
Arrhythmia	Experimental	This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment Receives: Drug: 18F-TPP
Treatment Failure	Experimental	A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T Receives: Drug: 18F-TPP

What is being measured

The primary outcome is the main question the study is designed to answer.

TPP imaging in Ventricular Arrhythmia
Establish imaging patterns allowing prediction of VT ablation failure
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 201730 Jun 2027

First posted29 Aug 2017
Study start14 Jul 2017
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (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 Arrhythmias, CardiacStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03265431
Sponsor's protocol ID: 2016P002123
Status last verified: Jan 2024
First submitted: 25 Aug 2017
Last updated: 30 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Pelletier-Galarneau M, Petibon Y, Ma C, Han P, Kim SJW, Detmer FJ, Yokell D, Guehl N, Normandin M, El Fakhri G, Alpert NM. In vivo quantitative mapping of human mitochondrial cardiac membrane potential: a feasibility study. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):414-420. doi: 10.1007/s00259-020-04878-9. Epub 2020 Jul 27.
PubMed 32719915

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
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Concomitant Procedures, Atrial Fibrillation

All Arrhythmias, Cardiac trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of PET/MR in Patients Selected for Ablation Therapy
ClinicalTrials.gov ID: NCT03265431
Acronym / sponsor ID: 2016P002123
Conditions: Arrhythmias, Cardiac
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 34 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 14 Jul 2017 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 29 Aug 2017 (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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control	Active comparator	Drug: 18F-TPPNormal subjects without history of cardiac disease or arrhythmia
Arrhythmia	Experimental	Drug: 18F-TPPThis cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment
Treatment Failure	Experimental	Drug: 18F-TPPA subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects must be ≥21 and ≤80 years of age;
Subjects must provide informed consent prior to study procedures;
Subjects must be ≥21 and ≤80 years of age;
Subjects must provide informed consent prior to study procedures;
History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided catheter ablation for clinical care

Key exclusion criteria (32 listed)

Known structural heart disease (e.g. myocardial infarction);
History of ventricular arrhythmia;
Any contraindication to MRI and/or PET, including:
Subjects with life vest;
Subjects with implanted heart device (e.g. ICD, Pacemaker);

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
18F-TPPAlso: 18F-BFPETImaging with 18-F-TPP (18F-BFPET)	Drug	Arrhythmia, Control, Treatment Failure

Primary outcome

TPP imaging in Ventricular Arrhythmia
Time frame: 5 years
Establish imaging patterns allowing prediction of VT ablation failure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Derived from this study: PubMed 32719915Pelletier-Galarneau M, Petibon Y, Ma C, Han P, Kim SJW, Detmer FJ, Yokell D, Guehl N, Normandin M, El Fakhri G, Alpert NM. In vivo quantitative mapping of human mitochondrial cardiac membrane potential: a feasibility study. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):414-420. doi: 10.1007/s00259-020-04878-9. Epub 2020 Jul 27.
Individual participant dataSharing planned: No

Related trials for Arrhythmias, Cardiac

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation

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?

A Phase 2 study testing 18F-TPP in people with Arrhythmias, Cardiac, run by Massachusetts General Hospital 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 5 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

TPP imaging in Ventricular Arrhythmia (time frame: 5 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 NCT03265431, 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 30 Jan 2024.