Atrial FibrillationNCT03811795
Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
A study testing ECG monitoring with a Kardia Mobile monitor in people with Atrial Fibrillation, run by Valley Health System at 3 sites in United States.
Trial summary
The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ECG monitoring with a Kardia Mobile monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Nov 2018to 26 Apr 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice;
- Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling institution more than 3 month or more prior to the anticipated repeat ablation;
- Age ≥ 18 years.
Who cannot join
- Individuals with recurrent AF who previously underwent RF-based PVI;
- Individuals with known contraindications to ablation including permanent atrial fibrillation or intolerance of anticoagulation;
- Individuals unable or not willing to complete follow-up visits and examination for the duration of the study;
- Individuals without access to smartphone or tablet compatible with the monitoring system;
- Prior valve surgery or surgical AF ablation;
- Individuals with mental or physical limitations precluding informed consent;
- Individuals currently enrolled in another investigational study or registry;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Valley Hospital
Paramus, New Jersey, 07652
Peace Health
Springfield, Oregon, 97477
Iowa Heart Center
West Des Moines, Iowa, 50266
About this study
Official title: Cryoballoon vs. Rhythmia Guided Ablation for Recurrent Atrial Fibrillation Following Initial Cryoballoon Pulmonary Vein Isolation
The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.
Read the detailed description
The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon PVI.
After obtaining informed consent to participate in the study, subjects will undergo baseline data bcollection. Subjects will then be randomized to undergo repeat PVI with either cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in accordance with standard clinical indications and practice, regardless of participation in the study.
The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram (ECG) at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile (AliveCor, Mountain View, CA) smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians. The transmissions will not be directly available to the treating electrophysiologists at each site.
At the 6 month visit, 2-weeks of continuous monitoring with a Zio XT event monitor (iRhythm, San Francisco, CA) will be performed according to standard clinical practice to evaluate for subclinical episodes of AF.
The goal of the pilot study is to enroll 50 subjects with 1:1 randomization across 3 sites in the Unites States and each subject will be followed for 6 months following ablation to evaluate for recurrence of AF. The estimated time to complete enrollment will be 3-4 months assuming enrollment of at each visit 4-5 subject per month at each site.
- Conditions
- Atrial Fibrillation
- Being tested
- ECG monitoring with a Kardia Mobile monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoring with a Kardia Mobile monitorOther
The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1-Repeat Cryoballoon Ablation | Other | Subjects will be randomized to repeat cryoballoon ablation. Receives: Other: ECG monitoring with a Kardia Mobile monitor |
| Arm 2-Radiofrequency Ablation | Other | Participants will have radiofrequency ablation guided by high-fidelity mapping (Rhythmia) following an initial cryoballoon ablation. Receives: Other: ECG monitoring with a Kardia Mobile monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
The freedom from atrial fibrillation at 6 months is the primary endpoint. The presence or absence of atrial fibrillation will be assessed during the study period.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start27 Nov 2018
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
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
- Model description
- The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon PVI. After obtaining informed consent to participate in the study, subjects will undergo baseline data collection. Subjects will then be randomized to undergo repeat PVI with either cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in accordance with standard clinical indications and practice, regardless of participation in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Advay Bhatt, MD, Principal investigator, The Valley Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811795
- Sponsor's protocol ID
- ABCRYO1786
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2018
- Last updated
- 24 Jun 2026
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon vs. Rhythmia Guided Ablation for Recurrent Atrial Fibrillation Following Initial Cryoballoon Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT03811795
- Acronym / sponsor ID
- ABCRYO1786
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 22 Jan 2019 (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 purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.
Detailed description
The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon PVI.
After obtaining informed consent to participate in the study, subjects will undergo baseline data bcollection. Subjects will then be randomized to undergo repeat PVI with either cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in accordance with standard clinical indications and practice, regardless of participation in the study.
The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram (ECG) at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile (AliveCor, Mountain View, CA) smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians. The transmissions will not be directly available to the treating electrophysiologists at each site.
At the 6 month visit, 2-weeks of continuous monitoring with a Zio XT event monitor (iRhythm, San Francisco, CA) will be performed according to standard clinical practice to evaluate for subclinical episodes of AF.
The goal of the pilot study is to enroll 50 subjects with 1:1 randomization across 3 sites in the Unites States and each subject will be followed for 6 months following ablation to evaluate for recurrence of AF. The estimated time to complete enrollment will be 3-4 months assuming enrollment of at each visit 4-5 subject per month at each site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon PVI. After obtaining informed consent to participate in the study, subjects will undergo baseline data collection. Subjects will then be randomized to undergo repeat PVI with either cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in accordance with standard clinical indications and practice, regardless of participation in the study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1-Repeat Cryoballoon Ablation | Other | Other: ECG monitoring with a Kardia Mobile monitorSubjects will be randomized to repeat cryoballoon ablation. |
| Arm 2-Radiofrequency Ablation | Other | Other: ECG monitoring with a Kardia Mobile monitorParticipants will have radiofrequency ablation guided by high-fidelity mapping (Rhythmia) following an initial cryoballoon ablation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice;
- Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling institution more than 3 month or more prior to the anticipated repeat ablation;
- Age ≥ 18 years.
Key exclusion criteria (8 listed)
- Individuals with recurrent AF who previously underwent RF-based PVI;
- Individuals with known contraindications to ablation including permanent atrial fibrillation or intolerance of anticoagulation;
- Individuals unable or not willing to complete follow-up visits and examination for the duration of the study;
- Individuals without access to smartphone or tablet compatible with the monitoring system;
- Prior valve surgery or surgical AF ablation;
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 |
|---|---|---|
| ECG monitoring with a Kardia Mobile monitorThe participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians. | Other | Arm 1-Repeat Cryoballoon Ablation, Arm 2-Radiofrequency Ablation |
Primary outcome
PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
Time frame: Six months
The freedom from atrial fibrillation at 6 months is the primary endpoint. The presence or absence of atrial fibrillation will be assessed during the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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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.
Advay Bhatt, MD principal investigator
The Valley Hosptial
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG monitoring with a Kardia Mobile monitor in people with Atrial Fibrillation, run by Valley Health System at 3 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib (time frame: Six months). 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 24 Jun 2026.