Recruiting

Cryo & Radiofrequency

Sponsor:

Sumit Verma, MD

Code:

NCT03148392

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.

Conditions

Atrial Fibrillation

Study ID

NCT03148392

Start date

May 16, 2017

Status verified date

Aug, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Nov 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.

Exclusion Criteria:

  • Persistent atrial fibrillation
  • Pregnant
  • Taking pain medications for acute or chronic conditions at the time of the procedure.
  • Undergo a combination of Cryoablation and Radiofrequency ablation
  • Radiofrequency group who undergo ablation beyond pulmonary vein isolation

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Cryo Balloon Ablation

Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference

Radiofrequency Ablation

Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference

Primary outcome measure

  • Pain Intensity Measurement [ Time Frame: 7 Days ]

Central Contacts and Locations

Central contacts

Research Manager

850-484-6690Jennifer.Lehmann@bhcpns.org

Locations

Cardiology Consultants

Recruiting

Pensacola, Florida, United States, 32501

Contacts

Research Manager

850-484-6690

More Information

Sponsor

Sumit Verma, MD

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sumit Verma, MD on 2019-08-28.