Trial Outcomes & Findings for Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia (NCT NCT03349892)

NCT ID: NCT03349892

Last Updated: 2021-11-15

Results Overview

ICD (implantable cardioverter defibrillator) shock free survival at six months

Recruitment status

COMPLETED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2021-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Ablation Treatment Arm This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Ablation Treatment Arm n=1 Participants This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Patients with refractory VT.

ICD (implantable cardioverter defibrillator) shock free survival at six months

Outcome measures

Outcome measures
Measure	Stereotactic Ablation Treatment Arm n=1 Participants This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.
ICD (Implantable Cardioverter Defibrillator) Shock Free Survival	1 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Single participant was lost to followup prior to 5-year assessment

Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Study participant was lost to follow-up prior to 5-year assessment

Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post-SABR procedure

Population: Subject was followed for 28 months.

Incidence of ICD shocks 12 months post-SABR procedure

Outcome measures

Outcome measures
Measure	Stereotactic Ablation Treatment Arm n=1 Participants This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.
Incidence of ICD Shocks	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Subject was not followed for 5 years

Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Subject was not followed for 5 years

Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of \>3 months over 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Subject was not followed for 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Followed for 10 years +

Population: Subject was not followed for 10 years

Outcome measures

Outcome data not reported

Adverse Events

Stereotactic Ablation Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert K. Chin, MD, PhD , Assistant Clinical Professor

University of California, Los Angeles

Phone: (310) 825-9771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place