Abbott Ventricular Tachycardia Post Approval Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05839873
• Collaborator: (none)
• Enrollment: 150
• Anticipated Duration (Months): 63

Study Details

Study Description

Brief Summary

This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Device: FlexAbility SE Ablation Catheter

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Abbott Ventricular Tachycardia Post Approval Study
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2028
• Anticipated Study Completion Date: Nov 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Treatment Group Single Arm Group to receive ablation.	Device: FlexAbility SE Ablation Catheter; Subjects receive ablation treatment.

Outcome Measures

Primary Outcome Measures

1. Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure. [12 Month]

2. Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation [12 Month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient must provide written informed consent prior to any clinical investigation- related procedure

2. Diagnosis of MMVT with non-ischemic structural heart disease

3. Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT

4. Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure

5. Able and willing to comply with all study requirements

Exclusion Criteria:

1. Documented or known intracardiac thrombus or myxoma

2. Active systemic infection

3. History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure

4. Patients with prosthetic valves as the catheter may damage the prosthesis

5. Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Kristin Ruffner, PhD, Clinical Program Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT05839873
• Other Study ID Numbers: ABT-CIP-10471
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular

Study Results

No Results Posted as of May 3, 2023