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TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02088606
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Device: TactiCath Quartz treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol
Study Start Date : March 2014
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TactiCath Quartz
TactiCath Quartz treatment
Device: TactiCath Quartz treatment
Catheter ablation for the treatment of paroxysmal atrial fibrillation


Outcome Measures

Primary Outcome Measures :
  1. Electrical isolation of all 4 PVs, or in the event of a common PV, the clinical equivalent of all PVs, by the end of index procedure [ Time Frame: 30 min post ablation ]
  2. Acute procedural success and freedom from recurrence of symptomatic AF, AFL, and AT lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period. Re-treatment for AF with ablation after 3 months is a failure [ Time Frame: 12 months post ablation ]
  3. Device-related early onset primary SAEs occurring within 7 days of the index procedure [ Time Frame: 7 days post ablation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic PAF (Paroxysmal Atrial Fibrillation)refractory to at least one Class I-IV antiarrhythmic drug
  • minimum one documented PAF episode >30 sec duration within prior 12 months
  • minimum three PAF episodes during prior 12 months
  • 18 years or older

Exclusion Criteria:

  • persistent or long-standing persistent AF(Atrial Fibrillation)
  • four or more cardioversions in prior 12 months
  • MI (myocardial infarction), CABG (coronary artery bypass graft) or PCI (percutaneous coronary intervention) within preceding 3 months
  • left atrial diameter > 5.0 cm
  • LVEF (left ventricular ejection fraction)< 35%
  • NYHA (New York Heart Association) class III or IV
  • previous left atrial ablation procedure
  • previous tricuspid or mitral valve repair surgery
Contacts and Locations

Information from the National Library of Medicine

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): NCT02088606


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02088606     History of Changes
Other Study ID Numbers: VP-002 527 Version H
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by St. Jude Medical:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes