Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib

NCT03811795 | Unknown DMC

• 1 other identifier: ABCRYO1786
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months

Study Arms (2)

Arm 1-Repeat Cryoballoon Ablation

OTHER

Subjects will be randomized to repeat cryoballoon ablation.

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.

Other: ECG monitoring with a Kardia Mobile monitor

Interventions

ECG monitoring with a Kardia Mobile monitor OTHER

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 1-Repeat Cryoballoon Ablation; Arm 2-Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valley Health System: lead

Study Sites (3)

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

RECRUITING

The Valley Hospital

Paramus, New Jersey, 07652, United States

RECRUITING

Peace Health

Springfield, Oregon, 97477, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Advay Bhatt, MD

  The Valley Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Sayles, BSN

CONTACT

201-389-0204; ksayles@valleyhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 22, 2019
• Study Start: November 27, 2018
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

US (3)