Atrial FibrillationSUBSTRATENCT02169037
Substrate Versus Trigger Ablation for Paroxysmal Atrial Fibrillation
A study testing FIRM Ablation and Conventional AF ablation with PVI in people with Atrial Fibrillation, run by University of California, San Diego at 2 sites in United States.
Trial summary
This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FIRM Ablation and Conventional AF ablation with PVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2016to 1 Jul 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female >21 years
- reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the three months preceding trial entry (at least 1 episode documented by 12-lead ECG or ECG rhythm strip)
- women without childbearing potential or women of childbearing potential who are not pregnant per a serum HCG test
- refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
- willingness, ability and commitment to participate in baseline and follow-up evaluations without participation in another clinical trial (unless documented approval received from both sponsors)
- oral anticoagulation required for those subjects who have a score of two or more based on the following criteria (CHAD score):
Show all 20Show fewer
- Congestive heart failure (1 point)
- hypertention (1 point)
- age 75 years or older (2 points)
- diabetes (1 point)
- prior stroke or transient ischemic attack (2 points)
- vascular disease (1 point)
- age 65 years or older (1 point)
- sex category: female (1 point)
- patient is willing and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects, and potentially indefinitely post procedure if the patient has CHAD score >or=2
- signed informed consent after a full discussion of the risks and benefits of both therapy arms, and the concept of randomization
- NYHA Class 0,I, II stable on medical therapy for > 3months
- left atrial diameter <or= 5.5cm
- LVEF >or=40%
- sustained AF during the procedure
Who cannot join
- atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, pericarditis)
- cardiac or thoracic surgery within the past 180 days
- AF secondary to electrolyte imbalance, thyroid disease
- contraindication to Heparin
- Contraindication to Warfarin or other novel oral anticoagulants
- history of significant bleeding abnormalities
Show all 28Show fewer
- history of significant blood clotting abnormalities, systemic thrombi or systemic embolization
- ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve
- atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) within 72 hours of the procedure
- intramural thrombus or other cardiac mass that may adversely effect catheter introduction or manipulation
- significant pulmonary embolus within 6 months of enrollment
- acute illness or active systemic infection or sepsis that may ordinarily warrant postponement of the procedure
- history of recent cerebrovascular disease (stroke or TIA) or systemic thromboembolism within < 6 months
- NYHA classes III, IV
- heart failure that is not stable on medical therapy
- pulmonary edema, that may make planned anesthesia or sedation difficult
- stable/unstable angina or ongoing myocardial ischemia
- myocardial infarction (MI) within the past three months
- structural heart disease of clinical significance including:
- congenital heart disease where the abnormality or its correction prohibit or increase the risk of ablation
- acquired heart disease that may increase risk of ablation, such as significant ventricular septal defect post myocardial infarction
- rheumatic valve disease, since this produces a unique AF phenotype
- extreme left atrial enlargement (LA volume index > 60 ml/m2) in whom PVI has low success and 55 mm baskets are too small for the atria
- cardiac transplantation or other cardiac surgery planned within the 12 month followup period of the trial
- life expectancy less than 12 months (the followup period of the trial)
- significant pulmonary disease (e.g., COPD) or any other disease that significantly increase the risk to the patient from sedation or anesthesia
- untreatable allergy to contrast media
- at time of ablation procedure, clinically significant abnormalities in serum potassium, sodium, magnesium or other electrolytes that affect the suitability of the patient for ablation at that time
Trial locations and contacts
2 sites in 1 country.
Sanjiv M Narayan, MD, PhD contact
Kathleen C Mills, BA contact
United States2 sites, 2 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Paul J Wang, MD, pjwang@stanford.edu
Sanjiv M Narayan, MD, PhD
- Recruiting
VA San Diego Medical Center
San Diego, California, 92161
David E Krummen, MD, 858-552-8585
About this study
Official title: Substrate Ablation (Focal Impulse and Rotor Modulation) Compared to Pulmonary Vein Isolation to Eliminate Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial
This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV isolation).
Read the detailed description
Pulmonary vein isolation (PVI) is a standard of care therapy for atrial fibrillation (AF). However, it produces suboptimal results, with a single procedure success of 45-55%, and multiple procedure success rates of 65-75% in recent randomized trials. The rationale of PVI is to eliminate triggers from the Pulmonary veins. An alternative strategy is to eliminate the substrates that sustain AF after it has been triggered, as applied to other arrhythmias. However, the relevance of AF substrates - at least in persistent AF - has been questioned with the recent STAR-AF-II trial, in which ablating at additional lines or complex atrial electrograms (CFAE) did not improve the success of PVI alone (Verma et al., 2015) - although success remained at ~50% for a single procedure. Because of STAR-AF2, the PVI limb in this trial will be PVI alone (wide area circumferential ablation) with no additional lesions.
Focal Impulse and Rotor Modulation (FIRM) is a novel approach to eliminate specific electrical substrates for AF, demonstrated in studies from many laboratories to take the form of localized electrical circuits. These rotors and focal sources lie in patient-specific locations, often away from typical PVI ablation sites and in right atrium, and ablating them has substantially improved the single procedure success rate of PVI in several multi center non-randomized trials (Narayan, J Am Coll Cardiol. 2012; Miller, J Cardiovasc Electrophysiol. 2014).
There is therefore equipoise in the literature between PVI alone, with a long-history but suboptimal results, and FIRM only, that is newer with potentially greater efficacy but without randomized trial data.
This study will test both strategies in a randomized controlled fashion.
- Conditions
- Atrial Fibrillation
- Being tested
- FIRM Ablation, Conventional AF ablation with PVI
- Keywords
- Rotor, FIRM, Paroxysmal Atrial Fibrillation, Atrial tachyarrhythmia, Ablation, Contact mapping, Clinical trial, Signal processing.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIRM AblationProcedure or surgery
Substrate ablation for AF, via ablation of rotors and focal sources alone.
Conventional AF ablation with PVIProcedure or surgery
Trigger Based Ablation for AF, using Pulmonary Vein Isolation alone.
| Study group | Role | What they receive |
|---|---|---|
| FIRM ablation | Experimental | These patients will be treated by ablation of patient-specific rotors and focal sources (FIRM) alone. Receives: Procedure: FIRM Ablation |
| Conventional AF ablation with PVI | Active comparator | These patients will treated by conventional AF ablation by pulmonary vein isolation (PVI) alone. Receives: Procedure: Conventional AF ablation with PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term success
Freedom from AF recurrence during 12 months after the initial AF ablation procedure, after an initial 3 month blanking (healing and stabilization) period
Measured: 12 months
Secondary outcomes (5)
Long-term freedom from AF/AT
Freedom from AF and atrial tachycardia (AT) during 12 months after the initial AF ablation procedure, after an initial 3 month blanking (healing and stabilization) period. Atrial tachycardias (AT) include those arising from atrial regions where ablation was performed (such as left atrial tachycardia) as well as from regions where ablation was not performed (such as typical cavotricuspid isthmus dependent atrial flutter).
Measured: 12 months
Total ablation time
Time from first ablation lesion to the last lesion. Total ablation time will be recorded in all patients, measured as the cumulative application of energy from the first ablation lesion to the last lesion. These values will be compared between the FIRM-guided and conventional ablation groups. If ablation for AT/atrial flutter is pursued, this ablation time will be documented separately.
Measured: 1 day
Quality of life (QOL)
Quantitative EuroQol EQ5D scores post-ablation will be compared to those pre-ablation at all time points separately and together (ANOVA).
Measured: 12 months
Adverse events
Adverse events will be adjudicated by an independent Data and Safety Monitoring Board, who will determine whether they are or are not related to the procedure. The number and type of adverse events will be compared between FIRM-guided and conventional ablation groups.
Measured: 12 months
Consistency of Sources At Repeat Ablation
Any patient with a recurrence who consents to restudy will have an assessment of whether rotors and focal sources lie at the same locations as they did at original study.
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 posted20 Jun 2014 (estimated)
- Study start1 Feb 2016
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sanjiv Narayan, MD, PhD, Stanford University
- Investigators
- Sanjiv M Narayan, MD, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169037
- Sponsor's protocol ID
- NAR083359
- Other IDs
- R01HL083359
- Acronym
- SUBSTRATE
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2014
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.e21. doi: 10.1016/j.hrthm.2011.12.016. Epub 2012 Mar 1. No abstract available.
PubMed 22386883Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
PubMed 22818076Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM. Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13.
PubMed 24632280Miller, J. M., R. C. Kowal, V. Swarup, J. P. Daubert, E. G. Daoud, J. D. Day, K. A. Ellenbogen, J. D. Hummel, T. Baykaner, D. E. Krummen, S. M. Narayan, V. Y. Reddy, K. Shivkumar, J. S. Steinberg and K. R. Wheelan (2014).
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Ablation (Focal Impulse and Rotor Modulation) Compared to Pulmonary Vein Isolation to Eliminate Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02169037
- Acronym / sponsor ID
- SUBSTRATE / NAR083359
- Conditions
- Atrial Fibrillation
- Keywords
- Rotor, FIRM, Paroxysmal Atrial Fibrillation, Atrial tachyarrhythmia, Ablation, Contact mapping, Clinical trial, Signal processing.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 20 Jun 2014 (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.
This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV isolation).
Detailed description
Pulmonary vein isolation (PVI) is a standard of care therapy for atrial fibrillation (AF). However, it produces suboptimal results, with a single procedure success of 45-55%, and multiple procedure success rates of 65-75% in recent randomized trials. The rationale of PVI is to eliminate triggers from the Pulmonary veins. An alternative strategy is to eliminate the substrates that sustain AF after it has been triggered, as applied to other arrhythmias. However, the relevance of AF substrates - at least in persistent AF - has been questioned with the recent STAR-AF-II trial, in which ablating at additional lines or complex atrial electrograms (CFAE) did not improve the success of PVI alone (Verma et al., 2015) - although success remained at ~50% for a single procedure. Because of STAR-AF2, the PVI limb in this trial will be PVI alone (wide area circumferential ablation) with no additional lesions.
Focal Impulse and Rotor Modulation (FIRM) is a novel approach to eliminate specific electrical substrates for AF, demonstrated in studies from many laboratories to take the form of localized electrical circuits. These rotors and focal sources lie in patient-specific locations, often away from typical PVI ablation sites and in right atrium, and ablating them has substantially improved the single procedure success rate of PVI in several multi center non-randomized trials (Narayan, J Am Coll Cardiol. 2012; Miller, J Cardiovasc Electrophysiol. 2014).
There is therefore equipoise in the literature between PVI alone, with a long-history but suboptimal results, and FIRM only, that is newer with potentially greater efficacy but without randomized trial data.
This study will test both strategies in a randomized controlled fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIRM ablation | Experimental | Procedure: FIRM AblationThese patients will be treated by ablation of patient-specific rotors and focal sources (FIRM) alone. |
| Conventional AF ablation with PVI | Active comparator | Procedure: Conventional AF ablation with PVIThese patients will treated by conventional AF ablation by pulmonary vein isolation (PVI) alone. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- male or female >21 years
- reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the three months preceding trial entry (at least 1 episode documented by 12-lead ECG or ECG rhythm strip)
- women without childbearing potential or women of childbearing potential who are not pregnant per a serum HCG test
- refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
- willingness, ability and commitment to participate in baseline and follow-up evaluations without participation in another clinical trial (unless documented approval received from both sponsors)
Key exclusion criteria (28 listed)
- atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, pericarditis)
- cardiac or thoracic surgery within the past 180 days
- AF secondary to electrolyte imbalance, thyroid disease
- contraindication to Heparin
- Contraindication to Warfarin or other novel oral anticoagulants
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 |
|---|---|---|
| FIRM AblationSubstrate ablation for AF, via ablation of rotors and focal sources alone. | Procedure or surgery | FIRM ablation |
| Conventional AF ablation with PVITrigger Based Ablation for AF, using Pulmonary Vein Isolation alone. | Procedure or surgery | Conventional AF ablation with PVI |
Primary outcome
Long term success
Time frame: 12 months
Freedom from AF recurrence during 12 months after the initial AF ablation procedure, after an initial 3 month blanking (healing and stabilization) period
5 secondary outcomes
Long-term freedom from AF/AT
Time frame: 12 months
Total ablation time
Time frame: 1 day
Quality of life (QOL)
Time frame: 12 months
Adverse events
Time frame: 12 months
Consistency of Sources At Repeat Ablation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 22386883Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.e21. doi: 10.1016/j.hrthm.2011.12.016. Epub 2012 Mar 1. No abstract available.
- Background: PubMed 22818076Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
- Background: PubMed 24632280Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM. Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13.
- BackgroundMiller, J. M., R. C. Kowal, V. Swarup, J. P. Daubert, E. G. Daoud, J. D. Day, K. A. Ellenbogen, J. D. Hummel, T. Baykaner, D. E. Krummen, S. M. Narayan, V. Y. Reddy, K. Shivkumar, J. S. Steinberg and K. R. Wheelan (2014).
- Individual participant dataSharing planned: No
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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.
Sanjiv M Narayan, MD, PhD contact
Kathleen C Mills, BA contact
Sanjiv M Narayan, MD, PhD study director
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIRM Ablation and Conventional AF ablation with PVI in people with Atrial Fibrillation, run by University of California, San Diego at 2 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 20 inclusion and 28 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 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Sanjiv M Narayan, MD, PhD (6507236393), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term success (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 NCT02169037, which also lists 4 linked publications.
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 4 Jun 2021.