Trial Outcomes & Findings for QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead (NCT NCT01733368)

NCT ID: NCT01733368

Last Updated: 2019-02-04

Results Overview

Structural remodelling is defined as a reduction \>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.

• Recruitment status: COMPLETED
• Target enrollment: 198 participants
• Primary outcome timeframe: 6 months after implant
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
Overall Study STARTED	198
Overall Study COMPLETED	167
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Baseline characteristics by cohort

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=198 Participants Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
Age, Continuous	66.01 years STANDARD_DEVIATION 10.22 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA I	5 Participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA II	77 Participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA III	111 Participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA IV	5 Participants n=5 Participants
Cardiovascular Etiology: Ischemic, Non-ischemic Ischemic	80 Participants n=5 Participants
Cardiovascular Etiology: Ischemic, Non-ischemic Non-ischemic	118 Participants n=5 Participants
QRS Duration	168 miliseconds (ms) STANDARD_DEVIATION 22.22 • n=5 Participants
QRS Morphology Left Bundle Branch Block (LBBB)	168 Participants n=5 Participants
QRS Morphology Right Bundle Branch Block (RBBB)	20 Participants n=5 Participants
QRS Morphology Interventricular Conduction Delay (IVCD)	8 Participants n=5 Participants
QRS Morphology Unknown	2 Participants n=5 Participants
Ejection Fraction (EF)	26.87 percentage (%) STANDARD_DEVIATION 7.38 • n=5 Participants
Left Ventricular End Systolic Volume (LVESV)	155.17 milliliters (ml) STANDARD_DEVIATION 75.10 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months after implant

Population: Patients with the 6-month follow-up completed and echocardiographic measurements available

Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.

Outcome measures

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=146 Participants Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead	6-Month CRT Non-Responder Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.
Number of Responder Patients (Structural Remodelling)	94 Participants	—

PRIMARY outcome

Timeframe: 6 months after implant

Population: Patients experiencing clinical safety event prior to the 6-month follow-up visit.

• Mortality rate,
• Rate of cardiovascular hospitalizations and for any cause or
• Combined endpoint (death and all-cause hospitalization)

Outcome measures

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=94 Participants Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead	6-Month CRT Non-Responder n=58 Participants Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.
Safety Outcomes in CRT Responders and Non-Responders Death	0 Participants	6 Participants
Safety Outcomes in CRT Responders and Non-Responders All-cause hospitalization	17 Participants	16 Participants
Safety Outcomes in CRT Responders and Non-Responders Deaths & Hospitalizations	17 Participants	20 Participants

SECONDARY outcome

Timeframe: 6 months after implant

Population: Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector

Response is defined as a reduction >15% in LVESV, measured 6 months after implant.

Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.

Outcome measures

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=59 Participants Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead	6-Month CRT Non-Responder Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.
Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector	38 Participants	—

SECONDARY outcome

Timeframe: 6 months after implant

Population: Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector

Response is defined as a reduction >15% in LVESV, measured 6 months after implant.

Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.

Outcome measures

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=87 Participants Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead	6-Month CRT Non-Responder Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.
Number of Responder Patients With Conventional Left Ventricular Pacing Vector	56 Participants	—

Adverse Events

Quadripolar Left Ventricular Lead (Quartet Lead)

Serious events: 50 serious events

Other events: 15 other events

Deaths: 6 deaths

Serious adverse events

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=198 participants at risk Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
Hepatobiliary disorders Acute Calculous Cholecystitis	0.51% 1/198 • 6 months after CRT implant
Cardiac disorders Atrial or Ventricular arrhythmia	5.6% 11/198 • 6 months after CRT implant
Surgical and medical procedures Bleeding/Hematoma	1.5% 3/198 • 6 months after CRT implant
Cardiac disorders Cardiac arrest and death	0.51% 1/198 • 6 months after CRT implant
Cardiac disorders Cardiac Tamponade	0.51% 1/198 • 6 months after CRT implant
Cardiac disorders Death	1.0% 2/198 • 6 months after CRT implant
Gastrointestinal disorders Diverticulitis	0.51% 1/198 • 6 months after CRT implant
Cardiac disorders Exacerbacion of Heart Failulre	4.0% 8/198 • 6 months after CRT implant
Cardiac disorders Exacerbacion of Heart Failulre and Death	0.51% 1/198 • 6 months after CRT implant
General disorders Malignant tumor	0.51% 1/198 • 6 months after CRT implant
Musculoskeletal and connective tissue disorders Musculoskeletal non-cardiac chest pain	0.51% 1/198 • 6 months after CRT implant
Cardiac disorders Myocardial infartion	0.51% 1/198 • 6 months after CRT implant
Respiratory, thoracic and mediastinal disorders Pneumonia	1.0% 2/198 • 6 months after CRT implant
Musculoskeletal and connective tissue disorders Rhabdomyolysis due to amiodarone and statins treatment	0.51% 1/198 • 6 months after CRT implant
Cardiac disorders stroke	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Cardiac perforation	0.51% 1/198 • 6 months after CRT implant
Product Issues Elevated Pacing Thresholds	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Infection	1.0% 2/198 • 6 months after CRT implant
Product Issues Lead Dislodgement	5.1% 10/198 • 6 months after CRT implant
Product Issues Phrenic Nerve/Diaphragmatic/Extracardiac stimulation	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Sepsis and Death	0.51% 1/198 • 6 months after CRT implant

Other adverse events

Measure	Quadripolar Left Ventricular Lead (Quartet Lead) n=198 participants at risk Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
Surgical and medical procedures Upgrade of the device to DDD by adding atrial lead	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Shiver and physical discomfort during implant	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Bleeding/Hematoma	3.5% 7/198 • 6 months after CRT implant
Surgical and medical procedures carbon dioxide narcosis	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Coronary sinus dissection	0.51% 1/198 • 6 months after CRT implant
Product Issues Inappropriate ATP	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Nause and vomiting	0.51% 1/198 • 6 months after CRT implant
Surgical and medical procedures Pain in the implant site	0.51% 1/198 • 6 months after CRT implant
Product Issues phrenic nerve/diaphragmatic/extracardiac stimulation	1.5% 3/198 • 6 months after CRT implant

Additional Information

Dr. Javier Alzueta Rodríguez

Hospital Clinico Universitario Virgen de la Victoria

Phone: 951 03 20 00

Email: jalzueta@telefonica.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place