Trial record 2 of 14 for:    contact AFL

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02088606
First received: March 12, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention
Paroxysmal Atrial Fibrillation
Device: TactiCath Quartz treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Device-related early onset primary SAEs occurring within 7 days of the index procedure [ Time Frame: 7 days post ablation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TactiCath Quartz
TactiCath Quartz treatment
Device: TactiCath Quartz treatment
Catheter ablation for the treatment of paroxysmal atrial fibrillation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088606

Contacts
Contact: Nicole Glowacki 6517563432 nglowacki@sjm.com

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sabina Sayeed       ssayeed@partners.org   
Principal Investigator: Moussa Mansour, MD         
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02088606     History of Changes
Other Study ID Numbers: VP-002 527 Version H
Study First Received: March 12, 2014
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Atrial fibrillation

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

ClinicalTrials.gov processed this record on July 28, 2014