Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03811795 |
|
Recruitment Status :
Recruiting
First Posted : January 22, 2019
Last Update Posted : March 30, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Other: ECG monitoring with a Kardia Mobile monitor | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Cryoballoon vs. Rhythmia Guided Ablation for Recurrent Atrial Fibrillation Following Initial Cryoballoon Pulmonary Vein Isolation |
| Actual Study Start Date : | November 27, 2018 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Arm 1-Repeat Cryoballoon Ablation
Subjects will be randomized to repeat cryoballoon ablation.
|
Other: ECG monitoring with a Kardia Mobile monitor
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. |
|
Arm 2-Radiofrequency Ablation
Participants will have radiofrequency ablation guided by high-fidelity mapping (Rhythmia) following an initial cryoballoon ablation.
|
Other: ECG monitoring with a Kardia Mobile monitor
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. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811795
| Contact: Kathleen Sayles, BSN | 201-389-0204 | ksayles@valleyhealth.com |
| United States, Iowa | |
| Iowa Heart Center | Recruiting |
| West Des Moines, Iowa, United States, 50266 | |
| Contact: Sara Burg, BSN 515-633-3845 scburg@iowaheart.com | |
| Principal Investigator: Troy Hounshell, DO | |
| United States, New Jersey | |
| The Valley Hospital | Recruiting |
| Paramus, New Jersey, United States, 07652 | |
| Contact: Kathleen Sayles, BSN 201-389-0204 ksayles@valleyhealth.com | |
| Principal Investigator: Advay Bhatt, MD | |
| United States, Oregon | |
| Peace Health | Recruiting |
| Springfield, Oregon, United States, 97477 | |
| Contact: Sherry Beaver, MS 541-222-1925 sbeaver@peacehealth.org | |
| Principal Investigator: Sree Karanam, MD | |
| Principal Investigator: | Advay Bhatt, MD | The Valley Hosptial |
| Responsible Party: | Valley Health System |
| ClinicalTrials.gov Identifier: | NCT03811795 |
| Other Study ID Numbers: |
ABCRYO1786 |
| First Posted: | January 22, 2019 Key Record Dates |
| Last Update Posted: | March 30, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |